Regulatory Focus™ > News Articles > 2019 > 9 > Recon: Court let Merck Hide Propecia Data; Sanofi to Pay Lexicon $260M to end Partnership

Recon: Court let Merck Hide Propecia Data; Sanofi to Pay Lexicon $260M to end Partnership

Posted 11 September 2019 | By Michael Mezher 

Recon: Court let Merck Hide Propecia Data; Sanofi to Pay Lexicon $260M to end Partnership

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Court let Merck hide secrets about a popular drug’s risks (Reuters)
  • Why Aren’t There Better Cancer Drugs? Scientists May Have Picked the Wrong Targets (NYTimes) (STAT) (Science) (Study)
  • ICER dings Novo's new oral diabetes drug (BioPharmaDive)
  • Purdue Close to Settlement with Cities and Half of States Over Opioid Crisis (WSJ) (Reuters) (CNBC)
  • Merck KGaA touts FDA 'breakthrough' status, blockbuster potential in bid to woo investors (Endpoints) (Reuters)
  • FDA is inspecting more foreign plants, but fewer domestic facilities (STAT)
  • No surprises in FDA staff review for Aimmune peanut allergy therapy (Endpoints) (FDA)
  • Trump Plans to Ban Most Vaping Flavors (WSJ) (CNBC) (Politico)
  • Apple will oversee new studies focusing on women’s health, hearing and mobility (CNBC) (NIH)
  • Scientists rethink Alzheimer’s, diversifying the drug search (AP)
  • Medicaid’s Dark Secret (The Atlantic)
In Focus: International
  • £200m largest ever genetics project launched to combat deadly diseases (Pharmafile) (UK Biobank)
  • Sanofi to pay Lexicon $260 million for terminated partnership (Reuters) (Endpoints)
  • After plenty of due diligence, GSK buys one biotech pup in the ‘$500M’ Avalon litter for its pipeline (Endpoints) (Pharmafile) (Press)
  • Italian gene therapy player draws new investor from China for its answer to CAR-T relapses (Endpoints)
  • How about a $477M biotech IPO amid Hong Kong protests? Henlius will find out (Endpoints)
  • Hong Kong strife holds up almost $100M of BioNTech's Series B haul (Endpoints)
  • Woodford fallout to blame for shrinking biotech valuations, co-investor says (Endpoints)
  • Novartis Inhaler is First Device to be Certified Under MDR (Focus)
  • EC Explains New MDR, IVDR Rules for Designating Expert Device Panels (Focus)
Pharmaceuticals & Biotechnology
  • When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates (Focus)
  • BIO’s new board chair on the industry’s bad reputation: ‘That’s ridiculous’ (STAT)
  • Pfizer hires ex-FDA, MD Anderson researcher as clinical oncology lead (Fierce)
  • Changing of the guard at Swiss biotech Vifor; nabs Sanofi exec as new CMO (Fierce)
  • GAO Reports on FDA, Drugmaker Efforts to Boost Access to Investigational Drugs (Focus)
  • Investors lost big as Alzheimer’s R&D went over the cliff in 2019. Will they ever come back? (Endpoints)
  • Penn team repurposes CAR-T cancer tech to treat heart disease (Fierce)
  • BioMarin talks down worries on gene therapy data differences (BioPharmaDive)
  • Most kids can manage pain after surgery without opioids (Reuters)
  • HPV vaccine offers some protection to men who aren't vaccinated, study finds (NBC)
  • Acadia calls early halt to Nuplazid psychosis trial after promising interim results (Fierce)
  • AI is changing the face of healthcare (Novartis)
  • FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office (Pink Sheet-$)
  • Gilead, Elton John AIDS Foundation launch HIV initiative (PharmaTimes)
  • Xeris scores first FDA nod with shelf-stable glucagon injector, syringe (Fierce)
  • Promising autoimmune biotech bought out as celiac drug heads for the clinic with a fresh infusion of cash (Endpoints)
  • Two commonly used uveitis drugs perform similarly in NIH-funded clinical trial (NIH)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Merck takes evobrutinib for MS into phase 3, on mixed data (PMLive)
  • FDA Confirms Omeros’ Schedule for Rolling Review of the Company’s BLA for Narsoplimab in the Treatment of HSCT-TMA (Press)
  • Puma Biotechnology Announces U.S. FDA Acceptance of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer (Press)
  • United Therapeutics Announces FDA Acceptance Of Trevyent New Drug Application For Review (Press)
  • Disarm Therapeutics Presents Data at ECTRIMS 2019 Supporting SARM1 as a Novel Therapeutic Target for Multiple Sclerosis (Press)
  • Nevakar Completes Enrollment for its Phase III CHAMP Study of NVK-002 (Press)
  • FORMA Therapeutics Announces Data for IDH1m Inhibitor Olutasidenib in Glioma to Be Presented at the 2019 Society for NeuroOncology Annual Meeting (Press)
Medical Devices
  • CDRH Committee Discusses Challenges in Communicating Cybersecurity Concerns (Focus)
  • Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device (Press)
  • Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity (Emergo)
  • European MDR covers cosmetic and aesthetic products: Are these firms ready? (Emergo)
  • PerkinElmer prices $850m offering (MassDevice)
  • iRhythm closes $115m offering (MassDevice)
  • Medtronic letter reveals Micra pacemaker deployment troubles (MassDevice)
  • Functional Neuromodulation launches Alzheimer’s DBS trial (MassDevice)
US: Assorted & Government
  • Not so fast: CDC isn't ready to blame illicit 'street vapes' for illnesses (Reuters)
  • FDA Bulk Drug List Updates Could Lead To Litigation (Law360-$)
  • FDA Giveth and Taketh Away as It Publishes Its Second Proposed Rule Concerning the Section 503A Bulk Substances List (FDA Law Blog)
  • It just got very hard for Amazon’s online pharmacy to access patient medication data (CNBC)
  • Google, Mayo Clinic strike sweeping partnership on patient data (STAT)
  • PML Valsartan Order (Drug & Device Law)
  • Dr. Reddy's, Hospira Want Full Fed. Circ. To Redo Lilly IP Win (Law360-$)
  • Stem Cell Biz Facing Fraud Claims Declares Bankruptcy (Law360-$)
Upcoming Meetings & Events Europe
  • EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante (Focus)
  • Payment For Outcomes Key To EU Market Access for Yescarta (Pink Sheet-$)
  • Infographic: Europe’s potential for biotech innovation (McKinsey)
  • Dutch Court Clears Doctor in Euthanasia of Dementia Patient (NYTimes)
India
  • DCGI approves manufacturing of new drugs at manufacturers’ multiple facilities (Pharmabiz)
  • DoP bans single-use plastic products in pharma trade, law to come into force from September 11 (Pharmabiz)
Canada
  • Teva’s biosimilar Herzuma cleared in Canada (PharmaLetter-$)
Other International
  • In Congo, Ebola Is Just One More Thing To Worry About (NPR)
General Health & Other Interesting Articles
  • Teens with illnesses want role in decision-making (Reuters)
  • Patients at for-profit dialysis centers less likely to get kidney transplants (Reuters)
  • Scientists Create A Device That Can Mass-Produce 'Synthetic' Human Embryos (NPR)
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.
 
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