Pharma News

This section covers the managerial aspects in the Pharma industry.

FDA approves Novartis biosimilar to Amgen's Enbrel

Wednesday, August 31, 2016

The US Food and Drug Administration on Tuesday approved Novartis AG39s biosimilar version of Amgen Inc39s arthritis drug Enbrel The FDA approved the drug Erelzi known also as etanerceptszzs for multiple inflammatory conditions including rheumatoid arthritis and plaque psoriasis a skin condition Th..

MDxHealth and Teva Pharmaceuticals Sign Distribution Agreement for SelectMDx in Israel

Wednesday, August 31, 2016

MDxHealth SA announced that it has signed a distribution agreement with Teva Pharmaceuticals to offer its SelectMDxTM for Prostate Cancer test to Teva39s urology customers throughout Israel Under the terms of the threeyear agreement Teva Pharmaceuticals will be the exclusive distributor of the Sele..

Elite Announces Development and License Agreement with SunGen Pharma LLC

Tuesday, August 30, 2016

Elite Pharmaceuticals Inc a specialty pharmaceutical company developing abusedeterrent opioids and niche generic products today announced it has entered into a Development and License Agreement Agreement with SunGen Pharma LLC SunGen to collaborate to develop and commercialize four generic pharmaceu..

Ferring Pharmaceuticals Acquires Exclusive Licensing Rights to Condoliase from Seikagaku Corporation

Tuesday, August 30, 2016

Ferring Pharmaceuticals announced today that it has signed an agreement with Seikagaku Corporation granting Ferring the exclusive worldwide rights excluding Japan to SI6603 condoliase a chemonucleolytic product in Phase III development for the treatment of radicular leg pain eg sciatica due to lumba..

Synlogic Proprietary Synthetic Biotic Receives FDA Orphan Drug Designation

Tuesday, August 30, 2016

Synlogic a privatelyheld biopharmaceutical company developing novel medicines based on its proprietary synthetic biology and microbiome platform today announced that the US Food and Drug Administration FDA has granted orphan drug designation to Synlogic39s investigational program involving a live E ..

Fuan Pharmaceutical Group plans new unit in Chongqing

Tuesday, August 30, 2016

Fuan Pharmaceutical Group Co Ltd Says it plans to set up a wholly owned subsidiary in Chongqing with registered capital of 10 million yuan and to transfer co39s production related asset and debt to the new subsidiary Says the book value of transferred asset is about 327 million yuan Source reut..

Aurobindo, Intas in race for $1 billion buyout of Teva UK, submit binding offers

Monday, August 29, 2016

Home grown drug makers AurobindoBSE 006 and Intas are among the final contenders for the UK and Irish portfolio of Israeli generics behemoth Teva put up for sale to comply with European antitrust regulations Both players have submitted binding offers of around 1 billion on Friday along with firm f..

Biotie Therapies: BTT1023 receives Orphan Drug Designation in US

Monday, August 29, 2016

FDA has granted Orphan Drug Designation for Biotie39s BTT1023 drug candidate for treatment of primary sclerosing cholangitis PSC BTT1023 is currently being studied for PSC in Phase 2a study BUTEO study Says twostage study design for BUTEO includes a preplanned interim analysis expected in first hal..

FDA warns former Sun Pharma U.S. drug factory over quality concerns

Saturday, August 27, 2016

The US Food and Drug Administration has pulled up a former Sun Pharmaceutical drug factory for knowingly releasing 27 lots of the hypertension drug clonidine last year despite proof that the raw materials used may have been contaminated This is one of a series of quality concerns tied to the Philad..

Britain's FTSE edges lower as pharmaceuticals weigh again

Saturday, August 27, 2016

Britain39s top share index edged lower on Friday set to finish the week with falls as recent weakness in the pharmaceuticals continued with investors wary over political risk in the sector By 0900 GMT the FTSE 100 was down 420 points or 01 percent at 681270 down 07 percent for the week and set for ..

BioLineRx and I-Bridge Capital Establish a New Drug Development Joint Venture in China

Friday, August 26, 2016

BioLineRx Ltd a clinical stage biopharmaceutical company dedicated to identifying inlicensing and developing promising therapeutic candidates announced today that it has established a joint venture JV with IBridge Capital a Chinese venture capital fund focused on developing innovative therapies in C..

Novartis announces positive phase III results for MS drug siponimod

Friday, August 26, 2016

Novartis AG said a latestage study showed its oral oncedaily BAF312 or siponimod reduced the risk of disability progression in a severe form of multiple sclerosis The Phase III EXPAND study the largest randomized controlled study in secondary progressive multiple sclerosis SPMS to date met its prim..

Mallinckrodt Receives FDA Fast-Track Designation for Synacthen® Depot IND Application

Friday, August 26, 2016

Mallinckrodt plc a leading global specialty pharmaceutical company today announced the US Food and Drug Administration FDA has granted the company39s request for a Fast Track designation for its Investigational New Drug IND application for Synacthen Depot in the treatment of Duchenne muscular dystro..

Mylan offers discounts on EpiPen amid wave of criticism

Friday, August 26, 2016

Mylan NV said on Thursday it would reduce the outofpocket costs of its emergency EpiPen allergy injection for some patients amid a wave of criticism from lawmakers and the public over the product39s rapidly escalating price The list price of the drug will remain the same but the company said it wou..

Pfizer Buys Part of AstraZeneca’s Antibiotics Business for $1.5 Billion

Thursday, August 25, 2016

Pfizer Inc has agreed to buy part of AstraZeneca PLCs antibiotics business for up to 1575 billion plus royalties in a move the US company said would boost the stable of older products it sells some of which have lost patent protection Under the terms of the deal Pfizer will pay Astra 550 million up..

Teva Plunges After Two U.S. Copaxone Patents Invalidated

Thursday, August 25, 2016

Teva Pharmaceutical Industries Ltd fell 3 percent after a US agency invalidated two of the patents protecting Copaxone a multiple sclerosis drug that generates 20 percent of its revenue The company said it will appeal The patents are among three being challenged at the US Patent Trial and Appeal Bo..

Mylan Faces Scrutiny Over EpiPen Price Increases

Thursday, August 25, 2016

Mylan NV became the latest pharmaceutical company to face popular outrage about higher drug costs as attacks mounted Wednesday on the companys substantial price increases for the EpiPen emergency allergy treatment EpiPen is a lifesaving treatment for millions whose allergies can send them into seve..

Nymox Pharmaceutical announces new long-term fexapotide placebo crossover study results

Thursday, August 25, 2016

Nymox reports successful new longterm fexapotide placebo crossover study results major reduction in incidence of surgery Results show there was 8295 pct reduction in number of these patients who required surgery after they received crossover fexapotide in trial Has completed and fully financed exe..

Anhui Fengyuan Pharmaceutical receives GMP certificate

Wednesday, August 24, 2016

Anhui Fengyuan Pharmaceutical Co Ltd Says it received goods manufacture practice GMP certificate from Anhui Food and Drug Administration Certificate issued to large volume injection manufactured by the company and the valid period is until Aug 15 2021 Source reuterscom ..

Strides Shasun gets USFDA tentative nod for Ranitidine tablets

Wednesday, August 24, 2016

Strides Shasun today said it has received an approval from the US health regulator for Ranitidine tablets used for treating intestinal and stomach ulcers and gastroesophageal reflux disease In a BSE filing Strides Shasun said it has received approval from the US Food and Drug Administration USFDA f..

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