Showing posts from September, 2009

Health Min seeks Cabinet nod for pentavalent combination vaccine programme

The Health Ministry has forwarded a proposal to introduce pentavalent combination vaccine for the cabinet approval so that it can be launched during the current financial year itself. The pentavalent combination vaccine of DPT - Hepatitis B - Hib (Haemophilus influenzae b) will be introduced in five States -- namely, Himachal Pradesh, Jammu and Kashmir, Karnataka, Kerala and Tamil Nadu -- during 2009-10 to 2011-12, after the cabinet gives sanction to it, sources said.   Before submitting the proposal, the health ministry has already consulted with the suppliers of the combination vaccines and reportedly got the assurance from the domestic industry for adequate supply. Domestic tenders will be floated for procurement after the clearance from the Cabinet. The expenditure finance committee has already approved the proposal and sanctioned Rs 400 crore for the project. The health ministry is also seeking funds from the World Bank for the project. The proposal has been pending for a

Sanofi Pasteur gets additional order from US government to produce Influenza A Vaccine

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that the company has received an additional order from the US Department of Health and Human Services (HHS) to produce vaccine to help protect against the Influenza A (H1N1) 2009 virus. The new order is for the production of bulk antigen equivalent to 27.3 million doses based on 15 mcg of antigen per dose. Specifications for formulation and filling of this new bulk order will be the subject of a separate order. To date, Sanofi Pasteur has committed to the US government a total of 75.3 million doses of Influenza A (H1N1) 2009 Monovalent Vaccine.

US FDA approves Bayer's blood glucose meter Contour USB

Bayer Diabetes Care announced US Food & Drug Administration clearance to market the Contour USB blood glucose meter. Bayer's Contour USB meter is the first and only blood glucose monitor that plugs directly into a computer providing users with instant access to information that can help optimize diabetes management. The Contour USB meter is integrated with Glucofacts Deluxe software for easy retrieval of data as well as longer-term tracking and analysis of blood glucose test results. Bayer's Contour USB meter is a cutting edge, premium meter that connects directly to a PC or MAC and the meter can store up to 2,000 test results. The built-in USB technology allows patients to simply plug in to gain knowledge about trends and patterns in their blood glucose levels. Ongoing data tracking and accurate information sharing are key to good diabetes management. The Contour USB meter facilitates data organization and management - transforming results into meaningful insights th

CDSCO sets up an office for export facilitation, another at state drug controller's premises

The setting up of the office of Central Drugs Standard Control Organization (CDSCO) in the Karnataka has come in a big relief for the pharma units in the state. There are two CDSCO offices opened in the state now. While one facility known is for the export office is at the Bengaluru International Airport, the other is located in the state drugs control office. Having a CDSCO office will now bring down the cost overheads and prevent inordinate delays for pharma manufacturers to seek the export clearances. The State's total pharma earnings is estimated at Rs 3,850 crore ending March 31, 2009 of which exports account for 8 per cent. The leading exporters are Biocon, Micro Labs, Bal Pharma, Medriech, RL Fine Chem, Strides Arcolab to name a few. All these years, companies sought the necessary clearances from the CDSCO at Chennai. The setting up of the CDSCO in Karnataka will now provide the much needed fillip to export activities. Right now there are two officials manning the oper

US FDA warns about stolen respiratory medications manufactured by Dey

The US Food and Drug Administration advised consumers not to use certain respiratory medications purchased after September 8, 2009 and manufactured by Dey LP, a subsidiary of Mylan Inc, because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Florida, on September 8, 2009. The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly. Dey issued an advisory on September 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Troikaa Pharma launches Xynova Endo for customized endoscopy procedures

Troikaa Pharmaceuticals has introduced a novel anaesthetic dosage, Xynova Endo, a Lidocaine Lozenge for customized endoscopy procedures in patients. The unique product is useful for anaesthetizing a patient's oral cavity or mouth during endoscopic procedures. Xynova Endo is an intra-oral anaesthetic dosage form comprising a Lidocaine Lozenge mounted on a unique holder just like a lollipop. The holder allows the patient to suck the lozenge gradually by rolling it in the mouth. The product is completely soluble, leaves no undissolved residue and provides a clear field of vision. Dosing can be initiated by a paramedic 10 minutes prior to the procedure, leading to time saving by the doctor. Lidocaine Lozenge ensures better patient compliance due to its pleasant taste, minimal irritation, and reduced need for sedation.   Lidocaine Lozenge is only sucked and must not be swallowed, broken or chewed. The mouth offers an attractive route of administration for delivery of this drug.

GENova Biotherapeutics inks deal with Beckpharma

GENova Biotherapeutics Inc (GENova), a biotechnology company that develops novel therapeutic proteins that disrupt the advance of life-threatening cancers, has signed a collaboration deal with Beckpharma Ltd (Beckpharma) - a pharmaceutical development company also involved in cancer treatments. The two companies are joining forces in their mutual mission to identify, acquire, and out-license promising cancer drugs in an effort that will not only save millions on GENova's R D budget, but at the same time will significant increase GENova's distribution, the deal with Beckpharma is the latest deal in a string of deals that GENova has recently done in a continued effort to increase its IP portfolio and increase its distribution network.

Paras Pharmaceuticals redesigns Moov

Paras Pharmaceuticals Limited, India's leader in the pain relief segment, announced its flagship over-the-counter brand Moov with contemporary design and a novel communication. A first in the rubefacient pain relief category, Moov has always been trusted relief from backache. Moov is powered with four active ingredients that act fast, penetrate deep to provide warmth and fast relief from pain. The Moov brand equity has also been leveraged into a different body part segmentation through the launch of Moov Neck & Shoulder.

Nanoparticle-based Erectile Dysfunction Therapy Shows Promise

An innovative drug-delivery system – nanoparticles encapsulating nitric oxide or prescription drugs – shows promise for topical treatment of erectile dysfunction (ED), according to a new study by scientists at Albert Einstein College of Medicine of Yeshiva University. The new system, tested successfully on a small number of animals, could potentially prevent side effects associated with oral ED medications, if study results can be replicated in humans. That could mean safer and more effective ED therapy for millions of men with heart disease and other health problems affecting erectile function. The study is published today in the online edition of the Journal of Sexual Medicine. Tens of millions of men worldwide have benefited from oral ED medications such as sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis). However, these medications - which belong to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors - have limitations. They can cause syst

Pieris AG Enters into Anticalin Collaboration With Allergan, Inc.

Pieris AG today announced that they have entered into a collaboration agreement with Allergan, Inc. (NYSE: AGN) that combines Pieris' proprietary Anticalin technology with Allergan's expertise in drug delivery and ophthalmic drug development with a goal of developing agents for the treatment of serious ocular disorders.   Under the terms of the collaboration Pieris will work with Allergan to optimize existing lead Anticalins and to design novel Anticalins. Allergan will be solely responsible for all discovery, development, and commercialization costs and will be responsible for clinical development and related activities and commercialization.   Pieris has granted Allergan a worldwide and exclusive license to Allergan for specific Anticalins to be used in the field and in return will receive an upfront payment of $10,000,000. Further financial terms were not disclosed.   Pieris is developing Anticalins for the treatment of a variety of disorders. Anticalins ar

Indian Govt begins efforts to establish Indian pharmacy chains in Africa to counter issue of fake drugs with 'made in India' label by China

In an effort to effectively counter the complex issue of spurious drugs with 'made in India' label but were produced by Chinese companies to tarnish the image of Indian generic drugs in the African countries, the Indian government has started initiatives to establish a chain of pharmacies in African countries by the reputed Indian pharmacy chains like Apollo Group and Hetero Group.   In the first phase, the pharmacy chains will be established in Nigeria in collaboration with local Nigerian companies. It was the Nigerian government which had recently seized a large consignment of fake anti-malarial drugs with the label of 'made in India' but was later found that the medicines were in fact produced in China and were imported into the African countries by the unscrupulous elements in China with the intention of tarnishing the image of emerging Indian generic drug business in the region. The authorities in Nigeria have maintained that the incident is not isolated, cal

Developing countries express concern over WIPO's hidden agenda of pushing patent harmonization

Even as the World Intellectual Property Organisation's (WIPO) two-day Global Symposium of IP Authorities is underway in Geneva, the developing countries are expressing concern on the larger agenda of the organisation, controlled by US, EU and Japan, on pushing a patent harmonization agenda.   According to WIPO, the symposium is being organised to discuss issues relating to the modernization and administration of IP Offices (Patent and Trademark Offices), brainstorm the vision for the future on the global IP infrastructure including common tools and databases for facilitating international collaboration, study the value of IP statistics for managing IP Office operation, and exchange experiences on the different financial models of IP Offices.   But, there are apprehensions among the developing countries over the larger intentions of the WIPO. It is evident from an analytical note issued by the South Centre, an intergovernmental organization of developing countries, which says,

GENova Signs Collaboration Agreement With Beckpharma

GENova Biotherapeutics, a US-based biotechnology company, has signed a collaboration deal with Beckpharma, a UK-based pharmaceutical development company involved in cancer treatments. The two companies are joining forces in their mutual mission to identify, acquire, and out-license promising cancer drugs in an effort that will not only save millions on GENova's R&D budget, but at the same time will significant increase GENova's distribution. This collaboration will bolster GENova's acquisition activities and funnel more promising drug targets into its drug development pipeline. GENova will also leverage the scientific expertise of Beckpharma's R&D team, as well as its established distribution channels with big pharmaceutical companies. Furthermore, scientists in both GENova and Beckpharma are examining their current IP portfolios to gain insight into possible synergies between their drug targets, and the possibility of making a stronger, better, combined

Link Between Doctors, Drug Firms Examined

Some British doctors see no conflict in saying they authored medical reports actually written by the pharmaceutical industry, critics said. "I do think there needs to be a national debate in this country about the interpenetration of medicine and the pharmaceutical industry," Tim Kendall, director of the National Collaborating Center for Mental Health, told The Guardian in a story published Saturday. The case of Britain bone specialist Richard Eastell highlights the issue, The Guardian reported. Eastell, a professor at Sheffield University, allegedly admitted he let his name be used as the author of a study of Actonel, an osteoporosis drug, manufactured by the U.S. company Proctor & Gamble. Eastell lacked access to all of the data on which the study was based, The Guardian reported, noting an employee of Proctor & Gamble wrote the study. Eastell is to be called before Britain's General Medical Council to determine whether he is fit to practice medicine,

AbD Serotec, FIND ink research alliance to develop temperature stable antibodies

MorphoSys AG announced that its research and diagnostic antibody segment AbD Serotec has initiated a research collaboration with FIND (Foundation for Innovative New Diagnostics), a Swiss foundation that develops, evaluates and accelerates the implementation of new diagnostic tools for poverty-related diseases such as TB, malaria and sleeping sickness. The goal of the research alliance is to establish a series of heat-stable HuCAL-based antibodies as key components of novel diagnostic tests that are robust in tropical climates. Using MorphoSys's proprietary HuCAL technology, AbD Serotec will identify heat-stable fully human antibodies specific for rapid diagnostic test applications for parasite detection. Financial details of the agreement were not disclosed.

MakroCare inks partnership with OmniComm

MakroCare, a global clinical services firm, providing clinical research support to pharma, biotech and medical device industries, is partnered with OmniComm Systems, Inc, one of the fastest growing companies and a leader in integrated electronic data capture (EDC) solutions for clinical trials.   MakroCare offers a best-of-breed suite of clinical technologies for managing global clinical trials, including customized interactive voice response (IVR) and web applications, comprehensive clinical trial management systems (CTMS) and drug safety and pharmacovigilance systems.  

Merck Serono gets Japanese nod for easypod

Merck Serono, a division of Merck KgaA Darmstadt, Germany, announced that the Japanese health authorities, the Pharmaceutical and Medical Devices Agency (PMDA), have granted a marketing authorization for easypod in Japan. Easypod was developed for exclusive use with cartridges of Saizen (somatropin), Merck Serono's human recombinant growth hormone for the treatment of growth hormone deficiency. Easypod is an innovative electronic auto injection device designed to improve ease of usage, reliability and convenience for patients who need daily subcutaneous injections of Saizen. It allows patients to self-inject in just three simple key steps. Additionally, a built-in dose memory automatically records the number of doses administered, allowing physicians and caregivers to accurately monitor patient adherence to therapy.

Health Care Index up by 35% from January, reaches to yearly peak level at 4040 in September

The Bombay Stock Exchange Health Care (HC) index of 21 major pharma companies touched to its 52-weeks highest level at 4040.45 points on September 18, 2009 on account of improved investor sentiment. With better than expected economic recovery, improved US numbers, limited foreign exchange losses in the current quarter and higher approvals in the highly regulated market offered the necessary push to HC index. At the close of the week ended September 2009, the HC index closed at 4023.54 points, a gain of 35.49 points as compared to 2990 points as at the first trading day closing of the year 2009.  

India accounts for low incidence of organ transplant due to lack of awareness and non compatible donors

India accounts for low incidence of organ transplant due to lack of awareness and non compatible donors, according to the Zonal Coordination Committee of Karnataka (ZCCK). The Committee which monitors the organs transplant programme in the state has noted that in the last two years only 12 cadaver donors have been able to save lives of 33 patients in the state. Many people in India die due to unavailability of the organs or lack of compatible donor within the family. There is also a serious lack of awareness to donate organs. Although one lakh people die in road accidents in the state, the organ donation is yet to take place. However, under the new amendment of the Organ Transplantation Bill, punishment against those involved in commercial organ trade has become severe. The bill says that those involved in the trade, including the doctors who help in the swapping will be levied a fine of Rs 10,000 to Rs 20,000. The amendments also entitle the living organ donors to benefits like

Ion Exchange develops polymeric adsorbents for pharma industry

Ion Exchange (India) Ltd has recently developed and commercialised several new polymeric adsorbents which find application in the pharmaceutical industry. Working on the Vander Waats forces principle, polymeric adsorbents INDION PA 500 & INDION PA 800 are capable of removing non-polar substances from polar streams. They are extremely effective in replacing activated carbon, and thus successfully address the carbon disposal issues, which is a serious issue facing the industry nowadays. Moreover, the surface of the adsorbents can be reactivated for repeated use, offering a distinct cost and environmental benefit. These polymeric adsorbents have been well received by the pharma industry as well as the biotech and process industries for applications of removal of non-polar impurities from fermentation broth, removal of polyphenol and chlorophyll from herbal extracts and removal of phenol from hydrochloric acid.

Glenmark Generics gets US FDA nod for Verapamil SR tabs

Glenmark Generics (GGL), a US subsidiary of Glenmark Phamaceutical, has received ANDA approval from the US FDA for Verapamil 240mg extended release tablets and will immediately commence marketing and distribution in the US market. Verapamil SR tablets are indicated for the management of essential hypertension and are the generic equivalent of Isoptin SR tablets. The 240 mg strength has more than half the market share of the overall Verapamil SR product line. Total sales for the twelve month period ending June 2009 was USD 65 million, as per IMS Health.

Rexahn Pharmaceuticals and Teva Pharmaceutical Industries Agree to Close on a License Agreement

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and central nervous system (CNS) therapeutics, today announced that it has reached an agreement to close on its previously announced licensing and stock purchase agreements with Teva Pharmaceutical Industries Limited, a top 20 pharmaceutical company, for the development of its novel anti-cancer compound, RX-3117. RX-3117 is a small molecule, new chemical entity (NCE), nucleoside compound that has an anti-metabolite mechanism of action, and has therapeutic potential in a broad range of cancers including colon, lung and pancreatic cancer. Closing of the transaction is expected to occur on September 21, 2009. The companies reached an agreement with respect to the commercialization and development of RX-3117, under which on September 16, 2009 Teva agreed to purchase shares of Rexahn's common stock for $3.5 million. Rexahn will be eligible to receive additional deve

Centre to amend Transplantation of Human Organs Act to impose strict penalties to violators

The centre has approved the Union Health Ministry's proposal to amend the The Transplantation of Human Organs Act, 1994 in order to make the organ transplantations more transparent and patient friendly, and also for imposing stringent penalties on persons/hospitals violating the provisions of the Act.   Though the central government had enacted The Transplantation of Human Organs Act to control the human organ trade in the country about 15 years ago, there were widespread reports of violations of the law by the unscrupulous elements in the country for economic gains. Experts in the human organ transplantation field have been demanding to the government to amend the law to curb the unlawful activities in the field also to make it patient-friendly. The Health Ministry's initiative in this regard comes in the wake of repeated reports about a thriving human organ trade in the country and the consequential exploitation of economically weaker sections of the society. There was

Matrix gets tentative US FDA approval for HIV/AIDS drugs

Matrix Laboratories, a Hyderabad-based subsidiary of Mylan Inc. has received tentative approval from the US Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg. Mylan's product represents the first-ever fixed-dose combination of efavirenz, lamivudine and tenofovir disoproxil fumarate and now provides Matrix with numerous tenofovir combination product opportunities. This new drug adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used for either first- or second-line treatment in adults. People use second-line therapies if and when they develop resistance to initially prescribed treatments.

Bavarian Nordic to supply smallpox vaccine Imvamune to EU country

Bavarian Nordic A/S has signed a contract with the military of an undisclosed EU country for the delivery of a small order for Imvamune. The vaccines will be delivered in 2009. The size and value of the contract is undisclosed. This marks the first time, Bavarian Nordic enters a contract with an EU country for the delivery of Imvamune, and it demonstrates that there exists a real demand inside of EU for new and safer smallpox vaccines for preparedness stockpiles.

Wockhardt Hospitals to provide first aid boxes for 300 police stations in Mumbai

Wockhardt Hospitals unveiled a programme called - 'Health First' for safety of Mumbai policemen. This programme is dedicated to the Mumbai police fraternity to support and take care of their emergency health requirement. Under this programme Wockhardt Hospitals will provide First Aid Boxes in 300 police stations across the city and will also have a training module to train the policemen on handling medical emergencies.

Stem cell therapy cures girl of thalassemia

Coimbatore-based Senthil Kumar's eight-year-old daughter Thamirabharuni had been cured of thalassemia - a genetic defect - through cord blood stem cell transplantation. For six-and-a-half years Thamirabharuni suffered from this fatal disease, going through painful blood transfusion and medication until stem cell transplantation using cord blood stem cells gave.   A newborn sibling's umbilical cord blood provides a better chance of HLA matching as there is a 25 per cent chance for a perfect match, and 50 per cent chance for a partial match. Also using a sibling's cord blood for transplant lowers the chances of donor rejection, and is therefore considered as a preferred source for transplantation compared to using stem cells from a non-related source.   Dr. Revathy Raj who examined Thamirabharuni, had recommended her to start on iron reducing medication initially. She had asked Senthil Kumar and his wife to consider another pregnancy and go for umbilical cord blood stem

Lupin and Novartis Resolve Patent Dispute Over Hypertension Drug

Indian pharmaceutical company Lupin and Swiss pharmaceutical group Novartis have reached an out-of court settlement over Novartis's hypertension drug sold under the brand name Lotrel, reported The Economic Times. According to the news source, the settlement allows Lupin to launch a generic version of the drug ahead of its patent expiry in 2017 and get a one-time revenue upside. Lupin intends to launch its generic version of Lotrel, a combination of amlodipine besylate and benazepril hydrochloride, within the next few years.  

Smokefree Mumbai campaign responds to recent study by BCM, Houston that claims smoking create stronger memory

It has been scientifically proven, time and again, that smoking leads to memory decline. Extensive research conducted by several reputed institutions, including the University College of London (UCL)(2003) the Erasmus Medical Centre, Netherlands(2008) and the University of Minnesota(2009) stand testimony to this long-standing fact. Yet, a study conducted recently, by the Baylor College of Medicine (BCM), Houston, claims smoking creates stronger memories.   Speaking on the issue, Dr Surendra Shastri, chairman of the Smokefree Mumbai campaign said, "The article from the Baylor College of Medicine published in media looks like a typical, out of context 'cut and paste' report of the original scientific article engineered by the tobacco lobby. Far from improving memory, a more recent publication (August 19, 2009) in the Journal of Neurology, Neurosurgery and Psychiatry, by Alvaro Alonso, MD, and colleagues from the University of Minnesota in Minneapolis, reported that curre

Ranbaxy Labs inks licensing pact with Medy-Tox to strengthen dermatological segment

Ranbaxy Laboratories Limited (Ranbaxy) has entered into a strategic in-licensing agreement for the Indian market, with Medy-Tox Inc (Medy-Tox), South Korea's largest Botulinum -Toxin specialized Biotech Venture, for its cosmetic product, Neuronox. The introduction of this new alternative brand of Purified Botulinum Toxin Type -A, will strengthen the company's presence in the Dermatological segment. Therapeutic equivalence and clinical trials conducted by Medy-Tox in various countries across the world, have confirmed the efficacy and safety of Neuronox in all respects. This product is now made available in India through Ranbaxy.

Bristol-Myers Squibb to sell OTC assets in Asia Pacific to Taisho Pharma for $310 mn

Bristol-Myers Squibb Company has reached an agreement for the sale of its OTC assets in Asia Pacific (excluding China and Japan) to Taisho Pharmaceutical Co, Ltd (Taisho).   Pursuant to the terms of the definitive agreement, Taisho will acquire from Bristol-Myers Squibb certain product registrations, trademarks and related assets of selected pharmaceutical and over-the-counter products sold primarily in Indonesia, Thailand and The Philippines, as well as in other countries in the Asia Pacific region, including the rights to the Tempra, Counterpain, Theragran-M, Engran, Ceetrus and Keri brands.   The transaction also includes Bristol-Myers Squibb's 97.97 per cent stake in PT Bristol-Myers Squibb Indonesia Tbk, and the land, buildings, product registrations, intellectual property, fixed assets, inventory and other related assets owned by BMSI as of the closing date. The aggregate purchase price to be paid by Taisho is $310 million. The closing of the transaction is expected to

India mulling ban on use of CFC-based inhalers for asthma, COPD

India is mulling more regulations to reduce the use of Chlorofluorocarbons (CFCs) in metered dose inhalers (MDI) used for asthma and chronic obstructive pulmonary diseases (COPD), even as efforts are being taken to further push the ongoing campaign for the use of CFC-free alternatives in the country, in line with the Montreal protocol. The authorities are taking views of the stakeholders to put in place regulations on priority to reduce dependence of CFC after launching the campaign for phasing out the CFCs. The ministries of health and environment would further interact with all the concerned including the pharma industry on the regulatory measures that can be introduced in this regard, sources said.   They are also weighing options including controlling the sale and distribution of CFC based MDIs and also banning manufacturing and import of CFC based MDIs with salbutamol, among other options. However, major agenda will be to evolve more mechanisms for phasing out these, it is l

Cipla, Meda extend rights for azelastine & fluticasone combination

Meda and Cipla Ltd, a leading pharma company in India, have expanded the existing long term collaboration agreement for the combination of azelastine and fluticasone.   Azelastine is an antihistamine and fluticasone a corticosteroid; both are indicated for nasal treatment of allergic rhinitis. As mono substances (in the antihistamine and corticosteroid markets respectively) they have leading positions in the US In the future, a combination of azelastine and fluticasone in a nasal formulation, may give patients with allergic rhinitis a more effective treatment than current therapies. In collaboration with Cipla, Meda has been developing this combination for the North American markets during the past years. The product is currently in phase III and the remaining clinical studies are expected to be completed during the second half of 2010.  

Mizoram bans sale of drugs not registered with it from Sept 1, industry protests

The industry has taken strong objection to the Mizoram state government's decision to make it mandatory for the drug companies to register each and every drug entering Mizoram from September 1 this year and levying a fee of Rs 50 per product in the name of averting spurious drugs.   While appreciating the state government's concern and consumer sensitivity to spurious drugs, the industry said that the method adopted by the government to stop the spread of spurious drugs is unheard of in the country so far as any unit, big or small, which is licensed under the Drugs & Cosmetics Act has a fundamental right to sell drugs throughout the country. Creation of such barriers for Small and Medium Enterprises (SMEs) to operate in parts of the country is not in consumer interest either.  

Industry upset over DCGI's new directive to state drug controllers

The pharmaceutical industry in the country is upset over Drug Controller General of India (DCGI)'s directive to the state drug authorities in which the DCGI is reported to have asked state authorities to implement the recent changes in law to punish companies making adulterated drugs as well as those drugs that copy an established brand but may not necessarily be harmful to consumers (spurious drugs).   The government had recently amended the Drugs and Cosmetics Act to enhance the punishment for manufacturing and marketing of spurious drugs. The government has also made this offence cognizable and non-bailable. Union health ministry had recently notified the Bill with the attachment of some safeguard guidelines.   The industry fears that as per the instructions of the DCGI, action will be taken by the state drug authorities even when there is dispute over brand name, design, colour scheme, trade address etc. These are Intellectual Property issues totally distinct from public

Trophos says TRO40303 significantly reduces myocardial infarct size and improves cardiac function

Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, announced demonstration of proof of principle that its proprietary compound, TRO40303 significantly reduces myocardial infarct size and improves cardiac function. The company presented information on two posters at the European Society of Cardiology (ESC) Congress 2009 held in Barcelona, Spain from 29 August to 2nd September.   Trophos expects the new presentations to help identify and obtain partners for this highly promising program for further development and commercialisation.

Galenica acquires Swiss company Om Pharma

Galenica acquires the entirety of Om Pharma, a fully integrated specialty biotechnology and pharmaceutical Swiss company with a unique expertise in the field of immunology. Om Pharma distributes in more than 90 countries and its products occupy a leading position in their markets. The acquisition confirms and supports Galenica's growth strategy: Om Pharma strengthens the Vifor Pharma business sector with a successfully established product portfolio in therapeutic areas which excellently complement Vifor Pharma's existing indication areas. Om Pharma's worldwide sales force reinforces deeply Vifor Pharma's network of partners, some of whom already distribute Venofer and Maltofer. Om Pharma will be managed as a profit centre of Vifor Pharma. The acquisition will be accretive for the Galenica Group results already in 2009.

19 pharma companies get '2009 India excellence in Healthcare Awards'

A total of 19 pharma companies in the field of medical devices, healthcare IT, medical imaging, drug discovery, biotechnology and clinical diagnostics have received the'2009 India excellence in Healthcare Awards' organised by Frost & Sullivan in Mumbai recently. These companies get the award for their outstanding contribution to the healthcare industry and would be the future drivers of growth through their market leadership, competitive strategies, and innovation.   The event was attended by the crème de la crème of the healthcare industry, focused on world-class companies that have performed par excellence and demonstrated best practices. Recognizing the best in class, the event was held to honour the country's premium players in the healthcare and research industry.  

Sanofi Pasteur signs pact with Butantan Institute to provide A(H1N1) vaccine to Brazilian govt

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, has signed an agreement with Butantan Institute for the production and supply of a vaccine against the novel A(H1N1) influenza virus for the Brazilian Government. This contract was announced during a state visit to Brazil by French President Nicolas Sarkozy. The order from the Brazilian Ministry of Health provides for the initial supply of 18 million doses of the new A(H1N1) influenza virus vaccine: one million doses in final presentation and 17 million doses in bulk form. The agreement includes an option for an additional 15 million doses of A(H1N1) vaccine should the World Health Organization (WHO) request influenza manufacturers to switch production from the regular Southern Hemisphere Seasonal influenza vaccine to the Pandemic A(H1N1) vaccine.

BD gets $52 mn US govt order for flu products

Becton, Dickinson and Company (BD) has received a significant order from the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HHS) for the purchase of syringes and needles, sharps collectors and alcohol swabs to be used in national flu pandemic preparedness efforts. Under the terms of the agreement, BARDA is authorized to purchase approximately $52 million of products from BD through March 2010.

Qiagen launches QIAsafe DNA blood kit for storage of blood samples

Qiagen launched the QIAsafe DNA blood kit to provide easy transport and storage of whole blood at room temperature. These kits are the first dry blood storage available on a matrix. The kits stabilize blood at ambient room temperature using an innovative technology. Biobanks are the intermediary between donors and research labs to ensure the safe effective transfer of the biological information held in samples. The number of biobanks is increasing, as is the cost for power to store the samples at the appropriate refrigerated temperature.  

Aurobindo receives US FDA and Swissmedic approvals

Aurobindo Pharma has received US FDA final approval for Risperidone oral solution 1mg/ml. The product is generic equivalent to Risperidal oral solution 1mg/ml of Ortho-McNeil Janssen. It is indicated in the treatment of schizophrenia and falls under the neurological segment. The product has a market size of approximately US$ 68 million for the twelve months ending March 2009 according to Newport. The company is going to launch this product in short time.   Similarly, Aurobindo has also received two approvals from Swissmedic, Government of Switzerland for the license of amlodipine APL 5 mg and 10 mg tablets and metformin APL 500 mg, 850 mg and 1000 mg tablets. Amlodipine APL tablets falls under the cardio vascular disorder therapeutic segment and is indicated for the treatment of angina pectoris and of mild to moderate hypertension, alone or in combination with other anti-hypertensives.  

Cornerstone gets US Bankruptcy Court okay to acquire rights to antibiotic factive from Oscient

Cornerstone Therapeutics Inc., specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, announced that it has received the approval of the United States Bankruptcy Court for the District of Massachusetts for its acquisition of the commercial rights to the antibiotic Factive (gemifloxacin mesylate) in North America and certain countries in Europe from Oscient Pharmaceuticals Corporation and expects to promptly close the transaction.  

Pharming seeks EMEA nod for Rhucin to treat hereditary angioedema

Biotechnology company Pharming Group NV announced that it has submitted the Marketing Authorization Application (MAA) for Rhucin for the treatment of acute attacks of hereditary angioedema (HAE) to the European Medicines Agency (EMEA). In this new MAA, Pharming has followed up on and addressed concerns raised by the CHMP during the former evaluation procedure in 2007. In particular, the size of the clinical database has been significantly expanded, additional clinical efficacy and safety data have been collected and analyzed, and an analysis of immunogenicity data after (repeat) treatment with Rhucin has been completed.

SIGA Technologies gets $3 mn research grant from NIH

SIGA Technologies, Inc., a company specializing in the development of pharmaceutical agents to fight bio-warfare pathogens, has received a phase II grant of approximately $3 million from the National Institutes of Health (NIH), to continue exploring the use of ST-246 as an adjunct to the current smallpox vaccine for prevention of smallpox vaccine-related adverse events. SIGA will evaluate the efficacy of ST-246 in preventing smallpox vaccine-related adverse events in non-human primate models of immunodeficiency and evaluate the impact of concurrent ST-246 administration on ACAM2000 vaccination efficacy in a monkeypox challenge in non-human primate models of immunodeficiency.