Regulatory Focus™ > News Articles > Regulatory Recon: Big Pharma Wary of Teva Joining Trade Group; BMS Buys Cancer, Rare Disease Firm Co

Regulatory Recon: Big Pharma Wary of Teva Joining Trade Group BMS Buys Cancer, Rare Disease Firm Cormorant (5 July 2016)

Posted 05 July 2016 | By Michael Mezher 

Regulatory Recon: Big Pharma Wary of Teva Joining Trade Group BMS Buys Cancer, Rare Disease Firm Cormorant (5 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Brand-Name Drug Makers Wary of Letting Generic Rival Join Their Club (NYTimes)
  • J&J's Janssen hit with $70 million verdict in Risperdal trial (Reuters) (Law360-$)
  • California Drug Price Plan Is Criticized by Patient Advocates (NYTimes)
  • Independence would be good for the FDA and the public (STAT)
  • Prominent Cardiologists Decry Tepid Support For Empagliflozin By Endocrinologists (CardioBrief)
  • Growing Pains for Field of Epigenetics as Some Call for Overhaul (NYTimes)
  • A Modern, Adaptive FDA Should Support Patients' Right To Try New Medications (Forbes)
  • J&J's insulin patch finally heading for launch (In-PharmaTechnologist)
  • Bristol-Myers Squibb buys cancer, rare disease biotech Cormorant (Fierce) (Press)
  • Where's the Drug, FDA? (WSJ-$)
  • Screening for health literacy is not the answer (The BMJ)
  • Tweeting and rule breaking at conferences (The BMJ)
  • Draft Scoping Document for ICER Review of Drugs for Relapsing-Remitting Multiple (ICER)
  • Top 10 pipeline blowups, setbacks and snafus in H1 2016 (Endpoints)
  • Can't Shake Failure Yet (In the Pipeline)
  • KaloBios Emerges From Ch. 11 With Chagas Drug Rights (Law360-$)
  • Could gene therapy become biotech's growth driver in 2017? (ORF Blog)
  • Breaking News: CAFC Affirms In Amgen v. Apotex (Big Molecule Watch)

In Focus: International

  • AstraZeneca, Genzyme named for ABPI code breaches (PharmaTimes)
  • Shortage of syringes hampers Congo's fight against yellow fever (Reuters)
  • Roche to cut around 350 IT jobs by end-2017 (Reuters)
  • Asia Regulatory Roundup: India Revises Draft Biosimilar Guidance (Focus)
  • Aurobindo Said to Enter Fray for $1.5 Billion Teva Portfolio (Bloomberg)
  • WHO Response to the US FDA Warning Letter issued for Shanghai Desano Chemical Pharmaceutical Co Ltd, Active Pharmaceutical Ingredient (API) Manufacturing Site (WHO)
  • Infringement procedure against Roche – EMA update (EMA)
  • For How Much Longer Is Your CE Marking Valid? The MDR Transition Arrangements (Clinica-$)
  • Sri Lankan court dismisses Roche's lawsuit to ban distribution of biosimilars produced by Biocad (PharmaLetter-$)
  • NICE rejects BMS' immunotherapy Opdivo for previously treated kidney cancer on pricing (Pharmafile)
  • NICE recommends FIRMAGON for men with advanced hormone-dependent prostate cancer and spinal metastases (MNT)
  • Brexit Talks Must Prioritize Patient Access, Avoid Regulatory Divergence – EFPIA (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Can A Safety Study Support A Superiority Claim? Barely, FDA Advisors Say (Pink Sheet-$)
  • Making Medicine Safer (Forbes)
  • Uterine cancer risk higher for women with 'breast cancer gene' mutation (Washington Post)
  • Deuterium switcheroo breathes life into old drugs (C&EN)
  • At Cancer Moonshot Summits, Questions But Few Answers (Medpage)
  • No Approval for Generic Product for Treatment of Rosacea (National Law Review)
  • Harvoni Rebates In Massachusetts Aim For Access, Not Savings (Pink Sheet-$) (BioCentury)
  • XBiotech Cancer Drug Survival Claim Falls Apart Under Scrutiny (The Street)
  • How The Marketing Of Clinical Trials Saves Lives (Forbes)
  • Be On The Lookout For New Innovations In Late Stage Studies (Cutting Edge Info)
  • J&J bags CD28 antagonist from OSE in €155M autoimmune deal (Fierce)
  • Celltrion Healthcare announces its commitment to develop anti-drug antibody and drug concentration assay to enable evidence-based decision-making in anti-TNF treatment (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Stem Cell Tx for ALS Called Safe in Early Study (Medpage)
  • Alnylam Advances RNAi Drug Results After Two Years of Treatment (Xconomy)
  • Araim Pharmaceuticals Receives Orphan Drug Designation from the US FDA for ARA 290 for the Treatment of Sarcoidosis (Press)
  • CEL-SCI Reports Monthly Patient Enrollment in June for Its Phase 3 Head and Neck Cancer Trial (Press)
  • FDA clears Biohaven's investigational new drug application for BHV-4157 and Portage to hold investor conference call to provide business update (Press)

US: Medical Devices

  • BioMérieux Gets Expanded FDA Approval for Sepsis Assay (GenomeWeb)
  • Cluster failure: Why fMRI inferences for spatial extent have inflated false-positive rates (PNAS)
  • TSO3 Receives U.S. Clearance for Extended Claims for Its Breakthrough Medical Device Sterilizer (Press)
  • Cartiva, Inc. Announces FDA Premarket Approval for Cartiva Synthetic Cartilage Implant (Press)

US: Assorted & Government

  • UnitedHealthcare Sues Dialysis Chain Over Billing (NYTimes)
  • Arizona Scraps Use of Sedative for Lethal Injections (NYTimes)
  • Circuit revives Bristol-Myers lawsuit over AIDS drug distribution deal (Reuters)
  • Diagnosing The Sequenom Problem (Law360-$)

Upcoming Meetings & Events

Europe

  • J&J's Siegel On Brexit: 'Our Objective Is To Minimize Any Disruption' (Pink Sheet-$)
  • Allergan says its double chin correction therapy Belkyra gets positive opinion from Swedish regulators (Pharmafile)
  • AZ, BMS and Boehringer among UK Prix Galien finalists (PMLive)
  • Amgen says its blood cancer drug gets European backing for extended indication (Pharmafile)
  • Biogen and AbbVie's Once-Monthly ZINBRYTA™ (Daclizumab) Approved in European Union for Treatment of Multiple Sclerosis (Press)

Asia

  • Eisai Launches In-House Developed Novel Anticancer Agent Lenvima In Mexico (Press) (Pharmafile)
  • GSK, Tsinghua in infectious disease partnership (BioCentury)
  • Galderma Announces Approval of Epiduo Gel for the Treatment of Acne in Japan (Press)
  • Sanofi, Regeneron say cholesterol drug Praluent approved in Japan (Pharmafile)
  • Takeda Submits a New Drug Application for Novel, Oral Proteasome Inhibitor Ixazomib in Japan (Press)
  • Takeda, Altos Therapeutics to develop Gastroparesis therapeutics  (BioSpectrum)
  • UCB scores Japanese approval for seizure therapy, Vimpat (Pharmafile)

India

  • India's pharma industry expected to grow to $55 bn by 2020 (Economic Times)
  • Sri Lanka woos Indian pharma companies to set up operations in the country (Economic Times)
  • Alembic Pharma gets tentative nod from USFDA for Febuxostat (Economic Times)

Australia

  • Corrections to Australian government's prostheses list have reimbursement implications (MassDevice)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
  • Medical Devices Safety Update, Volume 4, Number 4, July 2016 (TGA)

Zika

  • Sex May Spread Zika Virus More Often Than Researchers Suspected (NYTimes)
  • Obama says Congress must end deadlock on Zika funding (Reuters)
  • NIH funds Zika virus study involving U.S. Olympic team (NIH)
  • Health advice for people travelling to a Zika affected area (MHRA)
  • Guinea-Bissau confirms three cases of Zika virus, government says (Reuters)
  • Spain records first case of sexually transmitted Zika virus (Reuters)

Other International

  • WHO issues guidelines on validation on analytical method validation; expects industry to comment by month end (PharmaBiz)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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