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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities; Public
• Meeting – 29 April 2019

• 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)

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

• 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)

• 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)

• 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)

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