国际动态存档 （2015年7月1期）

• Cancer in Dogs Offers Insights for Humans

• BioMarin Provides Program Update for Talazoparib in Metastatic Breast Cancer

SAN RAFAEL, Calif., July 20, 2015 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced an update on the ABRAZO Phase 2 study of its poly ADP-ribose polymerase (PARP) inhibitor, talazoparib (formerly referred to as BMN 673) for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer. The company announced that the ABRAZO Phase 2 trial has met the study's protocol-specified threshold for documented tumor reduction (using the RECIST response rate criteria) in order to warrant expanding enrollment in the study from 70 to 140 patients....read more ...

• Exelixis Drug Slows Kidney Cancer In New Chance For Embattled Biotech

This morning, Bristol-Myers Squibb announced that its immunotherapy, Opdivo, also delayed cancer progression more than Afinitor in kidney cancer. This raises questions about the sales potential of Exelixis’ drug. On September 2, 2014, shares in Exelixis, a drug maker that has spent two decades trying to turn the early fruits of genetic research into drugs, plunged 48% as it announced that its cancer drug, Cometriq, did not extend survival in patients with advanced prostate cancer that had spread to their bones....read more...

• CheckMate -025, a Pivotal Phase III Opdivo (nivolumab) Renal Cell Cancer Trial, Stopped Early

• Gilead pushes some patients out of assistance program as it fights restrictive insurers

• Amgen's Blincyto puts leukemia patients in remission, building its case for a new FDA nod

• High blood pressure danger equal for slim and obese alike

• More Collaboration, Research Needed to Develop Cures

• Move West, Raise Cash: ProNAi’s Hot Streak Now Includes $138M IPO

• FDA Seeks Smooth PDUFA Renewal Process

FDA launched the process for reauthorizing the Prescription Drug User Fee Act (PDUFA) with a public meeting July 15, 2015, setting the stage for monthly discussions with industry beginning this fall and regular meetings for FDA to hear the views of patient, consumer and health professional representatives. The current program (PDUFA V) sunsets in September 2017, which means an agreement for PDUFA VI should be in place by the middle of next year.  FDA also has held kick-off meetings on new user fees for generic drugs and medical devices, which follow similar renewal timetables...read more...

• Gilead Limits Enrollment in its Hep C Patient Program to Pressure Insurers

In a bid to push back against payers, Gilead Sciences GILD -0.56% is limiting enrollment to its patient assistance program for hepatitis C drugs, which helps people obtain the Sovaldi and Harvoni treatments when they lack sufficient insurance coverage or the financial wherewithal to get the medicines otherwise...read more...

• Pharma M&A shoots up to $159B for first half, but prices could dampen the mood

• Endo whistleblower nabs $33.6M from feds for 'extraordinary' work in FCA suit

• FDA Approves First-of-Kind Leg Prosthesis

• GlaxoSmithKline joins the U.K.'s new Crick Institute for some open R&D

GlaxoSmithKline ($GSK) is the first pharma company to get behind the U.K.'s forthcoming Francis Crick Institute, signing on to lend its minds and molecules to an open R&D effort. Named for the famed co-discoverer of DNA structure, the Crick Institute is an under-construction London biomedical research outpost that will eventually employ 1,250 scientists with an annual budget of £100 million ($156 million). The Crick isn't expected to open its doors until next year, but GSK is getting in on the ground floor with a collaboration deal it believes can generate new ideas in infectious disease and cancer...read more...

• Takeda Submits New Drug Application for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma

• Running A Few Tests On Theranos: Can Elizabeth Holmes Revolutionize Diagnostics?

Elizabeth Holmes, the world’s youngest female billionaire, and her company, Palo Alto-based Theranos, have seized the public imagination with a vision of replacing traditional blood tests with a cheaper, faster, and less painful alternative. But Theranos’ technology remains shrouded in mystery, even controversy, as the company that aims to replace traditional blood tests with mere finger pricks begins to slowly expand from its initial footholds in California and Arizona...read more...

• The top 20 highest-paid biopharma CEOs

• Look out, Teva--Novartis' Copaxone generic is off to a speedy start

The launch for Glatopa, the new generic of Teva's ($TEVA) Copaxone from Novartis' ($NVS) Sandoz, is still in the very early going. But so far, things look good--very good--for the Swiss pharma giant. Through one week of launch, Glatopa racked up 18 prescriptions, and that number soared to 472 by the two-week mark, according to IMS Health data. And as Evercore ISI analyst Umer Raffat wrote in a Friday note to clients, that initial ramp looks a lot like that of Biogen's ($BIIB) high-flying Tecfidera and Teva's own long-lasting Copaxone, which has blown away analyst expectations....read more...

• AstraZeneca lung cancer drug approved as first-line treatment

• Dr. Reddy’s Announces the Launch of MEMANTINE HYDROCHLORIDE TABLETS, USP

HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories (RDY) announced today that it has launched Memantine hydrochloride tablets USP, 5 mg and 10 mg, a therapeutic equivalent generic version of NAMENDA® (memantine HCl) tablets in the US market on July 12, 2015, approved by the United States Food & Drug Administration (USFDA).

• Roche hustles to FDA with PhII PD-L1 cancer success for 'breakthrough' star atezo

• FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.Will public pressure drive the FDA to approve a so-so female libido drug?...read more...

• Will public pressure drive the FDA to approve a so-so female libido drug?

• Will India Issue a Compulsory License for an AstraZeneca Diabetes Pill?

• FDA approves Otsuka and Lundbeck's schizophrenia treatment

• $1,000-per-pill drug overtaken by pricier successor

• Novo Nordisk successfully completes first phase 3a trial with semaglutide in people with type 2 diabetes

• Samsung and Biogen plot an IPO for their biosimilars JV

• ISIS Pharmaceuticals Promoted to the Large-Cap Russell 1000 Index

• Why Higher BP May Protect Against Alzheimer's Risk

People with higher blood pressure may have a lower risk for Alzheimer's disease, a new study has shown. Findings from the study are published in PLOS Medicine. Researchers from the Brigham Young University evaluated data from the Alzheimer's Disease Genetics Consortium and the International Genomics of Alzheimer's Project that included 17,008 patients with Alzheimer's disease and 37,154 without the disease...read more...

• Watch Valeant Become The Berkshire Hathaway Of Drugs

Serial acquirer Valeant Pharmaceuticals Valeant Pharmaceuticals, an anointed stock in the portfolios of some of the largest hedge funds in Manhattan, appears to be on the prowl for a new takeover after closing its $11 billion acquisition of Salix Pharmaceuticals in mid-March. The Michael Pearson-led company has reportedly made an opening bid for Zoetis ZTS -0.64%, a $25 billion market capitalization leader in animal healthcare that was spun from Pfizer PFE -0.96% in early 2013...read more...

• Veggies & Proteins 1st, Then Carbs: Recommended Diabetics Chow Down

• Afrezza 5 Months Post-Launch Not too impressive but it could be worse

• Lilly Alzheimer's Drug Had Questionable Beginning

• Biotech’s Coming Cancer Cure

• Celgene pays $1B in landmark deal to buy into Juno's pipeline of CAR-T drugs