Latest Biotechnology, Pharmaceutical and Healthcare News from thePharmaLetter

Biogen Idec files BLA for MS drug Plegridy in USA

US biotech company Biogen Idec (Nasdaq: BIIB) has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for approval of Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for r...

New Zealand declines Alexion's funding application for Solaris

New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to decline the application from USA-based drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) for funding its drug Solaris (eculizumab) for the treatment of paroxys...

Vectura fiscal 201213 revenues beat own expectations, and loss narrows

UK inhaled therapies developer Vectura Group (LSE: VEC) yesterday presented its preliminary results for the year ended March 31, 2013, posting revenues slightly ahead of expectations at 30.5 million ($46.3 million), but down compared with 33 million...

CML drug revenue in Japan to grow, despite global decline, says GlobalData

Bucking a global trend of falling revenues, weak penetration of generic drugs and an increasing patient population will ensure steady growth of Japan's Chronic Myeloid Leukemia (CML) market over the next decade, forecasts a new report from research a...

Novo AS acquires Norway's Xellia Pharmaceuticals in $700 million deal

Denmark-based Novo AS, the holding company of the Novo Group and the major shareholder in Novo Nordisk and Novozymes, has purchased all shares of the Norwegian firm Xellia Pharmaceutical for around $700 million from 3i and other current shareholders....

Ignyta acquires Actagene Oncology and entry into cancer personalized medicine

Privately-held US biotechnology company, Ignyta, which engages in catalyzing personalized medicine in autoimmune diseases, says it has acquired Actagene Oncology, effective May 20. Actagene was a San Diego-based privately held biotechnology company f...

Is failure to adopt business process management putting the pharma industry at risk?

The dynamic pharmaceutical, biotech and life-science sectors are constantly evolving. With frequent mergers, acquisitions, competitive pressures and the need to meet stringent regulation, companies operating in this arena need to be able to analyze a...

Pace of drug approvals to moderate for global pharma companies, says Fitch Ratings

Global pharmaceutical novel drug approvals will moderate in 2013 due to the exceptional research success in 2012, according to a Fitch Ratings report.

Royalty Pharma ups bid for Elan to $12.50 a share

ot on the heels of Ireland-based drugmaker Elan Corp's (NYSE: ELN) own acquisition plans (it is to buy AOP Orphan and Newbridge Pharma and royalty deal with Theravance; The Pharma Letters May 20 and 13), private equity firm Royalty Pharma is continui...

Pfizer discontinues late-stage inotuzumab ozogamicin study in NHL due to futility

Global pharma behemoth Pfizer says it is discontinuing a Phase III randomized, open-label, two-arm study (B1931008) evaluating the safety and efficacy of the investigational drug inotuzumab ozogamicin in patients with relapsed or refractory CD22+ agg...

Germany's G-BA issues final assessment for Cell Thera's Pixuvri

USA-based Cell Therapeutics (Nasdaq: CTIC) says that Germany's Federal Joint Committee (G-BA) has issued its final benefit assessment report for Pixuvri (pixantrone), which is indicated as a monotherapy for the treatment of adult patients with aggres...

XenoPort drops MS drug after poor trial results

USA-based XenoPort (Nasdaq: XNPT) saw its shares fall 12.7% to $5.89 in mid-morning trading on Monday (May 20), after it revealed top-line results from its pivotal Phase III clinical trial of arbaclofen placarbil (AP) for the treatment of patients wi...

Actavis confirms plan to acquire Warner Chilcott, in $8.5 billion deal

US generics major Actavis (NYSE: ACT) revealed today (May 20) that it has entered into a definitive agreement to acquire Ireland-based specialty drugmaker Warner Chilcott (Nasdaq: WCRX) in a stock-for-stock transaction valued at around $8.5 billion (...

Positive Ph III results for Novo Nordisk's FIX derivative for hemophilia B

Danish insulin giant Novo Nordisk (NOV: N) says it has completed paradigm 2, the first Phase III trial with a long-acting FIX derivative, N9-GP (glycopegylated recombinant factor IX), for hemophilia B patients, with successful results. Paradigm 2 is...

CIS countries prepare for the introduction of drug reimbursement schemes

Russia, Ukraine and Kazakhstan have recently taken steps to introduce drug reimbursement schemes similar to those functioning in other countries. If introduced, these could completely change the operating environment on both the generic and innovativ...

Stallergenes and DBV Technologies partner on developing novel respiratory allergies treatments

French biotech firms DBV Technologies (Euronext: DBV), creator of Viaskin, a new standard in the treatment of allergies, and Stallergenes (Euronext Paris CAC small), worldwide leader in allergen immunotherapy, have entered into a strategic research p...

Lundbeck and Takeda's Brintellix shows positive results in Ph III major depression study

Danish CNS specialist Lundbeck (LUND: DC) and partner Takeda Pharmaceutical (TYO: 4502), Japan's largest drugmaker, are presenting new data on four pivotal studies on Brintellix (vortioxetine), a novel investigational drug, at the 2013 Annual Meeting...

Access to medicines in Europe: the EU cannot save banks while sacrificing people's health

In a seminar hosted last week by the Group of the Progressive Alliance of Socialists & Democrats (S&D) in the European Parliament and the Member of the European Parliament (MEP), Alejandro Cercas (S&D, Spain), six MEPs from various political groups,...

Greek research-based drugmaker group AIFD challenges generics assumptions in Draft Patent Law

One of the most important preconditions for Turkey to reach a reformist, sustainable economic growth with high-added-value and to attract more direct foreign investment is to create an effective patent system at international standards, protecting in...

HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst

While the risks involved in HIV vaccine development have turned Big Pharma away from pursuing a preventative vaccine, government-funded organizations and smaller biotech firms may provide the answer, a GlobalData analyst has said in a research note a...

Elan makes "transformational" acquisitions and a divestment

Ireland-headquartered Elan Corp (NYSE: ELN) (Elan) this morning announced a series of transactions designed to decisively transform and advance the company. Upon shareholder approval, the totality of these strategically driven decisions, in addition...

Drug prices to plunge as Indian government announces plans to regulate rates of 652 medicines

India's National Pharmaceutical Pricing Authority (NPPA) last week announced plans that will bring down the prices of essential medicines, increase the number of drugs under price control, and alter the way the government regulates prices in the 720...

SciClone gains China rights to Zensun's Neucardin

USA-based SciClone Pharmaceuticals (Nasdaq: SCLN) today announced that the Company has entered into an agreement with Zensun (Shanghai) Science & Technology granting SciClone a license and the exclusive rights in China, Hong Kong and Macau to promote...

Impax launches authorized generic of Zomig, as Mylan debuts copy of Tricor in USA

US drugmaker Impax Laboratories (Nasdaq: IPXL) says that its generics division, Global Pharmaceuticals, commenced shipment of an authorized generic version of Zomig (zolmitriptan) tablets and orally disintegrating tablets, 2.5mg and 5mg, in the USA,...

Number of new PBS medicines in Australia hits 20-year low

The number of new medicines listed on the Australian Pharmaceutical Benefits Scheme (PBS) in 2011-12 was the lowest for 20 years, according to a new report released today (May 20) by the Centre for Strategic Economic Studies and commissioned by the p...