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 $14.4M for micro-organ drug testing chips built from stem cells (Fierce)
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Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
- Tremfya gets FDA approval in moderate-to-severe plaque psoriasis (PharmaTimes)
- FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers (Press)
- WuXi Biologics Congratulates Amicus on Receiving FDA Breakthrough Therapy Designation for AT-GAA (Press)
- FDA expands indication for Soliqua® 100/33 (Press)
- Horizon Pharma plc Announces Phase 3 Confirmatory Trial Evaluating Teprotumumab (OPTIC) for the Treatment of Active Thyroid Eye Disease (TED) Met Primary and All Secondary Endpoints (Press)
- Pfizer Announces Serotypes Included in 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older (Press)
Medical Devices
- Guardant’s blood test might replace biopsies for some lung cancer patients, study says (STAT)
- FDA: Device Sterilizing Facility Shutdown Could Have Impact (Medpage)
- Vertos Medical’s spinal stenosis treatment wins CE mark (MassDevice)
- Abbott Offers up Rapid Influenza Diagnostic (MDDI)
US: Assorted & Government
- Hand over your Humira biosim launch plans, judge tells Boehringer in AbbVie patent fight (Fierce)
- Republicans promise to lower drug costs — don’t believe them (The Hill)
- Senate Finance hearings on nursing homes loom next week (Politico)
- Novartis Ducks More Damages In Whistleblower Suit (Law360-$)
- 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
- FDA Advisory Committee Calendar
- Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities; Public
- Meeting – 29 April 2019
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)
Date: March 4, 2019
Source: RAPS