Recon: BMS-Celgene Deal at Risk as Largest Shareholder Opposes Acquisition – Regulatory Focus

Posted 28 February 2019 | By Michael Mezher 

Recon: BMS-Celgene Deal at Risk as Largest Shareholder Opposes Acquisition
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Starboard to vote against Bristol-Myers Squibb’s Celgene deal (Financial Times) (Reuters) (STAT) (Endpoints) (Market Watch) (In The Pipeline)
  • Senator Sanders urges FDA to allow older versions of $375K drug (Reuters)
  • A $100 Genome Within Reach, Illumina CEO Asks If World Is Ready (Bloomberg)
  • Big pharma is embracing open-access publishing like never before (Nature)
  • Klobuchar defends her record on regulating medical devices (AP)
  • Gottlieb Testifies on Status of FDA Operations After Government Shutdown (Focus)
  • Did some pharma execs offer misleading testimony to a Senate committee? (STAT)
  • As Trump calls for an end to HIV epidemic, CDC reports progress has stalled (STAT) (AP)
  • Celgene CEO Alles to bag $28M if he departs after BMS merger (Fierce)
  • FDA plans first public hearings on legalizing CBD foods in April (CNBC)
  • Amarin CEO: ‘We're just getting started' in treating heart patients (CNBC)
  • ‘Miraculous’ stem cell therapy has sickened people in five states (Washington Post)
  • Gottlieb’s threat of federal vaccine mandates: questionable legality, poor policy (STAT)
  • After a slate of small, tack-on acquisitions, is Merck ready to pull the trigger on a big M&A deal? (Endpoints)
  • Maze Therapeutics raises $191m in genetic modifiers push (Financial Times) (Endpoints)
  • For Novartis, the Michael Cohen affair just won’t stay dead (STAT) (Endpoints)
  • Novavax shares plunge 65 percent as respiratory vaccine fails in late-stage trial (Reuters) (Endpoints) (Fierce)

In Focus: International

  • Ahead of key NASH readout, France’s Genfit readies plans for $100M US IPO (Endpoints)
  • Congo Ebola center set on fire after armed attack (Reuters)
  • Outcomes-Based Deals For Cancer Drugs In UK ‘Could Mean Faster Access’ (Pink Sheet-$)
  • Novartis faces shareholder criticism over drug prices at AGM (Reuters)
  • EU Pharma Alarmed By Regional Variations In ICH's Draft Biowaiver Guideline (Pink Sheet-$)
  • Médecins Sans Frontières On Drug Prices – You Can’t Negotiate Blindfolded (Health Policy Watch)
  • Early Epidiolex sales push up GW Pharma's stock (BioPharmaDive)
  • Patients to recieve MDMA-assisted psychotherapy on ‘compassionate' grounds in Israel (Pharmafile)
  • Auden Mckenzie and Waymade accused of illegal hydrocortisone agreement (PharmaTimes)
  • Merck Launches $6B Threat To Versum-Entegris Deal (Law360-$)
  • MHLW to Impose Administrative Fines Only on Misleading Ads, Eyes 4.5% Charge: PMD Law (PharmaJapan)

Pharmaceuticals & Biotechnology

  • The secret to a new drug could be hiding in your genes (MIT Technology Review)
  • US Must Rethink Biologic Naming Suffix, Says IGBA (Pink Sheet-$) (IGBA)
  • As biotech booms, contract research organizations like Charles River Labs cash in (STAT)
  • Robotic pill tech found to be safe, tolerable in early human study, paving ground for oral biologics (Endpoints)
  • Sage raises $575m ahead of FDA review date for Zulresso (PMLive)
  • FDA flags sanitation concerns at Akorn's Amityville plant (Reuters)
  • Dr. Reddy's solid dose plant pinched by FDA for missteps (Fierce)
  • Gene therapy progress spurs Sarepta buy of Myonexus (BioPharmaDive) (Law360-$)
  • Endo terminates $190M deal for sterile injectable player (Fierce)
  • ARM 2018 Data Repot (ARM)
  • New Study Suggests Diet May Affect Response To Cancer Immunotherapy Drugs (Forbes)
  • Finding New Uses For Old Drugs – A Lifeline For Rare Disease Patients (Forbes) (The Economist)
  • FDA is Working to Bridge Gaps and Meet Needs for Rare Disease Product Development (FDA)
  • 7 Tips for Biotech Companies Seeking Capital in a Volatile Market (Xconomy)
  • J&J bags option on AdoRx lung cancer drugs (Fierce)
  • Kaleido Bio Downsizes IPO, Raises $75M for Microbiome Drug Tests (Xconomy)
  • A Cloud Lab Dedicated To Cancer Drug Discovery (Forbes)
  • Scientists genetically modify yeast to produce CBD and THC (Pharmafile)
  • Radioactive cancer drugs could pose risk to cremation workers (Reuters)
  • With Bayer predicting slowdowns for Xarelto and Eylea, what will fill the gap? (Fierce)
  • New study finds no link between flu shots and miscarriages, allaying fears (STAT)
  • The polar vortex exposed a major flaw in our volunteer blood supply system (STAT)
  • FDA Warns Spanish Firm Over GMP, Data Integrity Issues (Focus)
  • Denali expands antibody discovery deal with AbCellera (Fierce)
  • Industry Groups Seek More Options In Responding To DSCSA Verification Requests (Pink Sheet-$)
  • sRNAlytics Receives FDA Support for AI-Powered Pathway Analytics Platform (Press)
  • Eagle Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2018 Results (Press)
  • Axial Biotherapeutics nets $25M for clinical gut-brain axis studies into autism and Parkinson’s (Fierce)
  • StemoniX rakes in $14.4M for micro-organ drug testing chips built from stem cells (Fierce)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations                   

  • Tremfya gets FDA approval in moderate-to-severe plaque psoriasis (PharmaTimes)
  • FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers (Press)
  • WuXi Biologics Congratulates Amicus on Receiving FDA Breakthrough Therapy Designation for AT-GAA (Press)
  • FDA expands indication for Soliqua® 100/33 (Press)
  • Horizon Pharma plc Announces Phase 3 Confirmatory Trial Evaluating Teprotumumab (OPTIC) for the Treatment of Active Thyroid Eye Disease (TED) Met Primary and All Secondary Endpoints (Press)
  • Pfizer Announces Serotypes Included in 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older (Press)

Medical Devices

  • Guardant’s blood test might replace biopsies for some lung cancer patients, study says (STAT)
  • FDA: Device Sterilizing Facility Shutdown Could Have Impact (Medpage)
  • Vertos Medical’s spinal stenosis treatment wins CE mark (MassDevice)
  • Abbott Offers up Rapid Influenza Diagnostic (MDDI)

US: Assorted & Government

  • Hand over your Humira biosim launch plans, judge tells Boehringer in AbbVie patent fight (Fierce)
  • Republicans promise to lower drug costs — don't believe them (The Hill)
  • Senate Finance hearings on nursing homes loom next week (Politico)
  • Novartis Ducks More Damages In Whistleblower Suit (Law360-$)
  • Amazon continues its push into the pharmacy business, and has appointed a 14-year vet to run it (CNBC)
  • Teva Can't Fight FDA's New Generic-Exclusivity Policy: Judge (Law360-$)
  • Hikma Urges Justices To Eye Ruling On Medical Treatment IP (Law360-$)
  • As Over 100 House Democrats Embrace ‘Medicare for All,’ a Party Division Appears (NYTimes)
  • HHS must act boldly to help African-Americans fight Alzheimer’s disease (STAT)
  • Measles outbreaks: Lawmakers tackle vaccine misinformation conspiracies (NBC)
  • Michigan’s Product Liability Immunity Statute Remains an Absolute Defense (Drug & Device Law)

Upcoming Meetings & Events
Europe

  • How to make submissions to the MHRA if the UK leaves the EU with no deal (MHRA)
  • First guidance on new rules for certain medical devices (EMA)
  • MHRA Spells Out Post-Brexit Regulation of Medical Devices Under No-deal Scenario (Focus)
  • EMA Urges Sponsors to Prep for Spike in Brexit-related Submissions (Focus)
  • EC Updates EU MDR/IVDR Implementation Rolling Plan (Focus)
  • EU Regulatory Roundup: UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments (Focus)
  • Drug Alert Class 4: Paracetamol Infusion, Accord. (MDR 07-02/19) (MHRA)
  • EU EFFORTS TURN TOWARDS DIGITAL FOR 2019 (ACRO)

Asia

  • Medtronic launches Grafton DBM in Japan (MassDevice) (Press)
  • China Strengthens Clinical Trial Approval Regulations (BioCentury)
  • Franco-Japanese pairing to promote Tenelia in China (PharmaLetter-$)
  • Asia Deal Watch: Bharat Expands Its Vaccine Holdings By Buying GSK’s Chiron Behring (Scrip-$)

India

  • CDSCO soon to come up with new amended rules and regulations for biosimilars and orphan drugs (PharmaBiz)
  • Lupin launches chronic angina treatment drug in the US (Economic Times)
  • Torrent Pharma recalls around 2.30 lakh bottles of high BP treatment tablets from US (Economic Times)
  • J&J resumes production of baby talc in India after tests find no asbestos (Reuters)

Australia

  • Prescription medicines: new or extended uses, or new combinations of registered medicines, 2018 (TGA)
  • Prescription medicines: registration of new generic medicines and biosimilar medicines, 2018 (TGA)

Canada

  • Innovus Pharma Announces the Approval of its BH™ Testosterone Booster Product in Canada for the Indication to Help to Support Testosterone Levels and Production in Adult Males (Press)

General Health & Other Interesting Articles

  • Diabetes tied to risk for more advanced, aggressive breast cancer (Reuters)
  • Add Whooping Cough To The Growing List Of Vaccine-Preventable Epidemics (Forbes)

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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Source: https://www.raps.org/news-and-articles/news-articles/2019/2/recon-bms-celgene-deal-at-risk-as-largest-shareho