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Novartis biosimilar takes aim at Amgen drug Neulasta

RegulatorReuters2015-11-18 16:02 Read   337

FDA has accepted Novartis unit Sandoz's submission for approval of a biosimilar version of U.S.-based Amgen's Neulasta drug that fights infections in cancer patients, the Swiss group said on Wednesday.

Celltrion Submits Second Biosimilar for Approval to European Regulator

RegulatorBusiness Korea2015-11-18 15:12 Read   413

South Korean biopharmaceutical firm Celltrion announced that it filed a request for European Medicines Agency (EMA) approval of CT-P10 on Nov. 10 (local time)

Employee No. 1: Doug Williams launches exosome R&D player Codiak Bio with $80M-plus

CommentsJohn Carroll2015-11-18 14:05 Read   363

Doug Williams is now happy to reveal just why he stepped aside four months ago as R&D chief of Biogen ($BIIB).

Stepped-up Nucynta sales push starts paying off for Depomed

EVENTSDepomed2015-11-17 17:33 Read   265

Depomed's ($DEPO) relaunch of the Nucynta franchise--purchased earlier this year from Johnson & Johnson ($JNJ)--is off to a running start.

Catalent stops production at French plant, brings in law enforcement after it twice detects tampering

EVENTSCatalent2015-11-17 16:29 Read   389

Catalent has halted production at a softgel capsule manufacturing facility in France at the request of regulators after several incidents in which it appears someone within the plant purposely mixed the wrong capsules into batches. The company said it is working with French law enforcement and regulators to find out what happened.

Moving on from Novartis, Array inks a $455M oncology deal with Pierre Fabre

EVENTSArray2015-11-17 15:12 Read   219

Array BioPharma ($ARRY), hunting for partners after Novartis ($NVS) walked away from a pair of cancer projects, has linked up with Pierre Fabre to co-develop the treatments in an agreement worth up to $455 million.

Data from ALLY-3+ Trial Investigating Daklinza (daclatasvir) in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C Genotype 3 Patients with Advanced Fibrosis or Cirrhosis Presented at AASLD

TrendBristol-Myers Squibb2015-11-17 14:08 Read   448

Daclatasvir+sofosbuvir+ribavirin regimen for 12 or 16 weeks achieved SVR12 rates of 88% and 92%, respectively, in genotype 3 patients with advanced fibrosis or cirrhosis

Arrowhead Presents Data Showing Robust Sustained Anti-viral Effects with ARC-520 in Hepatitis B Infected Chimpanzees

TrendArrowhead Research Corp2015-11-16 17:18 Read   762

Arrowhead Research Corporation , a biopharmaceutical company developing targeted RNAi therapeutics, presents data at the AASLD Liver Meeting 2015 in an oral presentation and a poster showing that ARC-520, its drug candidate against chronic hepatitis B infection (HBV), leads to robust, sustained anti-viral effects in chimpanzees with chronic HBV.

Exclusive: U.S. drug benefit managers clamp down on specialty pharmacies

EVENTSREUTERS2015-11-16 10:01 Read   265

In recent days, the largest U.S. managers of private prescription drug benefits have cut off at least eight pharmacies that work closely with drugmakers, intensifying scrutiny of a system that helps inflate drug prices, officials at the benefit managers told Reuters.

Merck Provides Update on REVEAL Outcomes Study

EVENTSMerck2015-11-16 09:13 Read   205

Merck, known as MSD outside the United States and Canada, today announced that the Data Monitoring Committee (DMC) of the REVEAL outcomes study for anacetrapib has completed its planned review of unblinded study data and recommended the study continue with no changes.

Merck may appeal to Supreme Court after again losing fight to protect Cubicin patents

EVENTSMerck2015-11-15 10:09 Read   242

Merck & Co. ($MRK) is running low on options after a federal appeals court Thursday again declined to back four patents that would have held at bay for 5 more years generics of the antibiotic Cubicin, the drug that was key to its $9.5 billion buyout of Cubist. Next up may be an appeal to the U.S. Supreme Court.

Regeneron plots a $150M R&D expansion, adding 300 jobs at its New York hub

CommentsRegeneron2015-11-14 21:54 Read   209

Regeneron Pharmaceuticals ($REGN), riding high with a top-selling eye drug and some promising pipeline assets, is planning to invest $150 million in its native New York, supporting 300 new jobs at its fast-growing R&D campus.