Top Stories News

The award recognizes Rentschler for its flexible, multi-product manufacturing facility designed to minimize manufacturing costs and product cycle times.

India and Tunisia will launch joint research programmes in the field of biotechnology, medical sciences and other allied sectors of the science and technology.

The acquisition gives Amgen access to a novel cancer treatment.

The acquisition makes Watson the fifth-largest generic pharmaceutical company in Australia in terms of revenue, and the second largest in terms of total molecules possessed.

Celgene will acquire Avila Therapeutics for $350 million in cash.

Pharmaceutics International, Inc. has begun construction of a new cGMP aseptic fill/finish manufacturing facility.

Jazz Pharmaceuticals has bought Irish firm Azur Pharma in a deal that creates a specialty drug company headquartered in Dublin.

The MHRA certificate covers general GMP manufacturing operations, and laboratory controls designed for the production and release of APIs and intermediates.

The Japanese company will consolidate its R&D sites and functions, cutting its global workforce by approximately 2,800 by the end of fiscal 2015.

Novartis received Chinese regulatory approval for its eye drug Lucentis, and it is launching the diabetes treatment Galvus in China.

Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer's disease.

The alliance will pursue systematic and unbiased approaches towards the identification of kidney disease relevant mechanisms, with particular interest in mechanisms with disease-modifying potential.

Scil Proteins has signed a supply agreement with Actavis for the manufacturing of Reteplase.

The acquisition will extend Carbogen Amcis’ range of development and manufacturing services by adding formulation, lyophilization services and sterile GMP capabilities for the fast supply of drug products.

Around 150 staff from Almac’s Clinical Services Business Unit have moved to the new offices to consolidate the group.

Teva is looking towards Asia for acquisitions, hoping to expand into a market where generic use will increase.

The restructuring was prepared to respond to the loss of patent exclusivity for Diovan, the market-leading hypertension medication, expected in the US in September 2012.

The companies will collaborate to develop novel drug candidates against multiple targets across different therapeutic areas.

A delegation from the U.S. met India's Union Health and Family Welfare Minister for a bilateral meeting focused on the progress of the US India Health Initiative launched in 2010.

The firms have signed an agreement to set up a joint venture to develop and commercialize branded generic drugs for the Chinese market.

Pfenex will provide ProZyme with exclusive access to the Pf?nex Expression Technology platform for the production of an initial set of three undisclosed proteins.

Foundation will use its genomic sequencing and analytic capabilities to identify genetic biomarkers and potential companion diagnostics for select Sanofi oncology drug candidates.

PledPharma has restarted the MANAMI study with the collaboration with Recipharm to ensure new clinical trial material.

Sigma-Aldrich has agreed to acquire bioharmaceutical testing services company BioReliance for $350 million.

BMS enjoyed a successful year, with several pipeline drugs reporting positive trial results and clearing regulatory hurdles.

The visit will commence from February 12 and the three-member delegation will inspect six manufacturing units in China.

Bristol-Myers Squibb will acquire Inhibitex with an aggregate purchase price of approximately $2.5 billion.

ChemoCentryx will receive an option exercise fee of $25 million and will be eligible for further regulatory and sales milestone payments, as well as royalties on sales.

Each partner will receive worldwide rights to develop and commercialize a limited number of antibodies against each therapeutic target generated by AnaptysBio.

AIC246 (Letermovir) has been granted Orphan Drug Designation in the US for the prevention of HCMV viremia and disease in at risk populations.

The agreement will focus on discovering small molecule drugs against oncology-relevant protein-protein interactions.

The proposed guidelines cover five main areas: Good Importation Practices, Counterfeit Drugs and Medical Devices, Best Practices to Combat Counterfeit Drug and Medical Devices, Diversion and Theft, and Natural Disasters.

The combined entity offers a comprehensive portfolio of methods validation and testing services for biotechnology, pharmaceutical and consumer products manufacturers, raw materials suppliers and manufacturers of agricultural and veterinary medicine pro...

The companies will collaborate on initial research and Ironwood will be responsible for worldwide development and commercialization of all products incorporating BNC210 or other licensed compounds.

Biogen Idec has the option to license ISIS-SMNRx until completion of the first successful Phase II/III trial.

Servier will have access to BioInvent's in-house pre-clinical capacities in selecting an antibody candidate for development.

Isotechnika has inked a deal with Swiss-based drug maker Vifor to commercialize the company’s lead drug candidate voclosporin for treatment of lupus.

Teva has named Dr. Jeremy Levin, a former senior executive at Bristol-Myers Squibb, to succeed Shlomo Yanai as new CEO in May.

Under the terms of the Agreement, Regeneron will make payments to Genentech based on U.S. sales of EYLEA through May 7, 2016.

Alexion Pharmaceuticals plans to buy drug developer Enobia Pharma in a deal that could be worth $1.08 billion.

OPKO Health has completed the acquisition of Israel-based FineTech which produces high potency active pharmaceutical ingredients.

The restructuring provides UCB with the flexibility to select a partner to sublicense its rights for certain territories.

The change in the council’s name is to have a better visibility and to give more exposure of the council’s activities in the national and international forums.

Boehringer Ingelheim is investing €70m in China to expand its Shanghai manufacturing facility.

Eisai has resubmitted the New Drug Application for the investigational AMPA-type glutamate receptor antagonist perampanel.

The collaboration aims to discover and develop novel small molecule RORgamma modulators for the treatment of autoimmune diseases.

Marina Biotech could receive up to $63 million in total up-front fees as well as clinical and commercialization milestone payments over and above royalties on sales.

Takeda will use its own sales organization to market the once-daily tablet for patients with chronic obstructive pulmonary disease.

Baxter will make an upfront cash payment of $33 million to Momenta related to the collaboration for as many as six follow-on biologic compounds.

The transaction is expected to be finalised in January 2012 under an agreement worth $190m upfront and up to $120m in additional potential clinical development milestone payments.

Lilly will use ImmunoGen's maytansinoid Targeted Antibody Payload technology with Lilly monoclonal antibodies to develop novel ADC anticancer therapeutics.

Arecor will develop stable aqueous or higher concentration formulations of emerging protein and peptide drug candidates developed by Lilly.

Biotechnology and pharmaceuticals were the top areas for investment, with around 30% going to each area. The therapeutic areas of oncology, neurology and infectious diseases saw the most investment.

The transaction is expected to close by February of 2012. ForteBio will become a wholly-owned subsidiary of Pall Corp.

Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

Pfizer and GSK will supply hundreds of millions of additional doses of pneumonia vaccine to an international partnership for immunization to children in developing countries.

The proposed transaction has a total equity value of approximately $314 million on a fully diluted basis. In addition, ISTA has net debt of approximately $13 million, bringing the total enterprise value to approximately $327 million.

Mr. Sharer will step down as CEO effective May 23, 2012, and remain as chairman until December 31, 2012.

The two firms have signed an extension of their strategic alliance for a further two years to accelerate their clients’ drug discovery projects into development.

A new report says the costs associated with the diagnosis and treatment of cancer in the UK will dramatically increase by 2021.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirms that the benefit-risk balance of somatropin-containing medicines remains positive.

Enlight Biosciences has formed new partnerships with UK-based AstraZeneca and Denmark-based Novo Nordisk for the development of potentially transformational technologies.

Eisai has submitted a marketing and manufacturing authorisation application in Japan to seek approval of a new dry syrup formulation of Aricept.

Kymos Pharma Services has signed an agreement with the French multinational group Ipsen to take in a team of eight scientists from Ipsen R&D Centre.

Since the approval, more than 28,000 patients have received the pill to date and no deaths have occurred until now.

Cubist Pharmaceuticals has completed the acquisition of Adolor Corporation for an aggregate upfront cash consideration of approximately $221 million.

Simcere will receive exclusive rights to develop and commercialize BMS-795311 in China while Bristol-Myers Squibb will retain exclusive rights in all other markets.

The agreement is intended to expand the portfolio of Baxter’s regenerative medicine and biosurgery franchise, which includes a number of devices and biological products for hemostasis, tissue sealing and adherence.

Having originally planned to end the project in 2017, Merck now intends to continue its efforts to fight schistosomiasis indefinitely.

The acquisition is a further step in ICON’s on-going expansion in China and the greater Asia-Pacific region.

Abbott and Reata will equally share costs and profits for all new AIMs in all newly licensed indications, except for rheumatoid arthritis and select other autoimmune diseases.

Combining Novozymes' IP and expertise around the albumin molecules with Upperton’s rP-conjugate albumin conjugation chemistry knowledge, enables the companies to design and implement the best chemical linking approach for their molecule.

Several life-sciences organisations have worked on the project with IBM Research gaining access to a chemical library extracted from worldwide patents and scientific abstracts.

The agreement will establish a standardized testing protocol across the ACORN network of oncology community practices and hospitals with treatment guidelines and clinical trial opportunities.

IGI Laboratories has entered into a strategic partnership with Medimetriks to develop and manufacture prescription topical drug products.

This new cooperation project builds on the results of the Endometriosis biomarker discovery study performed last year.

The new facility will include three individual cGMP compliant production suites that will increase Phase I and II production capacity to 1,000L bioreactors.

This change to the US sales force is incremental to the ongoing second phase of the company's restructuring programme that was announced in January 2010.

A new report predicts that the Chinese pharmaceutical market will experience sustained double-digit growth over the next decade.

The new facility is part of the company’s $1.5 billion investment in R&D in China during the next five years.

Samsung and Biogen Idec will invest $300 million to establish a joint venture for the development, manufacture, and commercialization of biosimilars.

Takeda will establish a Vaccine Business Division to strengthen the Company’s foundations for expansion of its vaccine business on a global scale.

GSK decided not to pursue development based on its internal evaluation criteria, allowing Unigene to regain exclusive worldwide rights to the oral PTH program with no financial obligations to GSK.

Pharma giant Pfizer has announced that the acquisition of Excaliard Pharmaceuticals has been completed.

The companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens.

Stellar Pharmaceuticals has acquired Tribute Pharmaceuticals to create a leading North American specialist pharmaceutical company.

Boehringer will produce ficlatuzumab for clinical trials and AVEO retains all rights to develop and commercialize ficlatuzumab.

MacroGenics and Servier have entered into an option for a license agreement for the development and commercialization of MGA271.

Increased access to HIV services resulted in a 15% reduction of new infections over the past decade and a 22% decline in AIDS-related deaths in the last five years.

Jakarta-based Prodia will provide Quintiles with exclusive access to Prodia’s harmonized central laboratory for a two-year period.

Univar has expanded its distribution agreement with Innophos to distribute the latter’s full range of specialist phosphates in Turkey.

The Germany-based contract manufacturer's site in Japan was successfully inspected without any significant observation being issued.

The Mexican plant will be capable of supplying enough glass containers, ampoules, vials and cartridges for pharmaceutical use to satisfy North American market demand, as well as South and Central American markets.

GVK Bio will be responsible for the target validation, lead identification and lead optimization of small molecules in selected therapeutic areas.

Summit's DMD therapy has earned the US FDA orphan drug status.

If the European Commission concludes that Johnson & Johnson and Novartis break European Union anti-trust laws, the EC could impose huge fines.

Russia’s accession agreement will cause its import duties to fall across the board, and importers of pharmaceuticals will no longer need import licences.

The UK will select Merck's Gardasil vaccine instead of GSK's rival product Cervarix to prevent girls from contracting the HPV virus.

XEN-D0501 is currently being assessed for efficacy in overactive bladder in an international phase 2 clinical study.

Data demonstrated a median overall survival of 24.6 months from diagnosis, which is consistent with the finding of two earlier studies.

The transaction establishes a U.S. presence for Asahi Kasei Pharma and provides access to the global development and commercialization of ART-123.

Hikma Pharmaceuticals will be responsible for the registration and commercialization of perifosine in the Middle East and North Africa region.

Merck has reached settlement with federal and state authorities over arthritis treatment Vioxx and will pay nearly $1bn in the settlement.

Pfizer has signed an agreement to acquire privately owned biopharmaceutical company Excaliard Pharmaceuticals.

Gilead Sciences, the world’s largest maker of HIV medicines, plans to buy Pharmasset Inc. for about $11 billion.

Sundia MediTech was named one of the 50 best companies for investment in China in 2011 by Zero2IPO.

Par Pharmaceutical Companies Inc. has announced the completion of the acquisition of privately-held Anchen Pharmaceuticals.

The new co-promotion agreement is a partnership of mutual commitment between Eisai and Novartis Pharma.

FDA is revoking the approval of the breast cancer indication for Avastin after concluding that the drug has not been shown to be safe and effective for that use.

According to the EMA, the benefits of buflomedil-containing medicines do no longer outweigh their risks, and marketing of these medicines should be suspended throughout the EU.

Bayer aims to achieve a more than 60 percent increase in its sales in Asia by 2015, and all the Asian countries are intended to play a part in achieving the sales increase targeted for 2015.

The collaboration aims to identify compounds known as 'correctors,' which may aid in the ability of the malfunctioning CFTR protein found in CF patients to operate correctly.

Sources said that the delegation has been postponed to the fourth quarter of this financial year as the financial allocation of the ministry for the third quarter has finished.

Through the strategic partnership, UCB will receive the benefits of PAREXEL's proven clinical processes through all phases of development, which are supported by its market-leading eClinical technology platform.

Boehringer Ingelheim has invested over $350 million in its U.S. operations this year to enhance its drug discovery, development and manufacturing capabilities.

The UAE Ministry of Health has reduced the prices of 115 drugs in the country to support the partnership strategies between the department and local and international pharmaceutical companies.

Under the agreement, Oregon-based Bend Research will provide Merck with access to its proprietary spray dried dispersion (SDD) technology.

The World Health Organization has praised the UK for being one of the best prepared countries for future flu pandemics.

ArQule and Daiichi Sankyoa have announced their license agreement for the development of new AKT inhibitor ARQ 092.

The alliance is a sales and cost share agreement. Under the terms of the agreement, Lundbeck will make an upfront payment upon signing of USD 200 million (approximately DKK 1.1 billion).