Recon: Allergan to Recall Textured Breast Implants in Canada; FDA Expands Revlimid Label

• J&J's greed helped fuel US opioid crisis, Oklahoma claims at trial (Reuters) (NYTimes)
• BioMarin says data shows hemophilia gene therapy effects could wane (Reuters) (Xconomy)
• Seniors' spending on cancer drugs has soared (Axios)
• FDA first as agency expands label on Celgene's Revlimid in previously treated follicular or marginal zone lymphoma (Pharmafile) (Press) (FDA)
• A lifesaver with a catch: Powerful new cancer drugs can trigger diabetes — and no one is certain why (STAT)
• New Gilead chief O’Day axes worldwide ops chief and recruits Bristol-Myers’ Johanna Mercier for the top team (STAT) (Fierce) (Press)
• Amarin gets a boost from the FDA as regulators promise speedy Vascepa decision — but what about that panel review? (Endpoints)
• Maryland creates drug affordability review board (BioCentury)
• GSK prevails in Paxil preemption case as Supreme Court refuses review (Fierce) (National Law Review)

• Allergan to recall textured breast implants in Canada (Reuters)
• UK refuses to back 'game-changing' resolution on drug pricing (The Guardian)
• 6 months later, gene-edited babies stir new interest, debate (AP)
• Bayer to work with Foundation Medicine on selecting cancer patients (Reuters)
• UK institute, Belgian firm team up for African swine fever treatment (Reuters)
• China's driving sales growth ahead of the U.S. for Big Pharma. But can it last? (Fierce)
• Chinese pharma group admits using false documents (Financial Times)
• Invossa Approval Revoked As Korea Confirms False Data Submission (Pink Sheet-$)
• Inovio shares fall as AstraZeneca pares down partnership (Fierce)
• Fertility clinics around the world asked ‘CRISPR babies’ scientist for how-to help (STAT)
• Pharma firms paid Italian doctor to promote opioid drugs (Pharmafile) (AP)
• IPO boom: Antibody experts at Genmab outline global ambition in pitch for $500M (Endpoints)
• Oxford Biomedica gets £53m cash injection from Novo venture arm (PMLive)
• Companies Keep The Faith As New Products Await EMA Verdict (Pink Sheet-$)
• WHO counts down Africa polio clock despite fears of new outbreak (Reuters)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019 (EMA)

• Of Microbes And Men (LifeSciVC)
• Novartis backs $30M round for cancer biotech; Bayer drug makes a ‘breakthrough’ at FDA (Endpoints)
• US dentists prescribe opioids far more often than British counterparts (Reuters)
• The Biotech IPO Queue Grows Longer as Five More Companies File (Xconomy)
• Immunotherapy Is Now Here For Breast Cancer. What Are Its Prospects? (Xconomy)
• Orphan Drug Designation: The Gift That Keeps On Giving (Lassman Law+Policy)
• Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing (FDA)
• Data Integrity Compliance Experts Are Urging Industry to Apply Regulator Perspective and Learnings in Refining Data Systems and Auditing (IPQ)
• Ready to harvest its PD-L1, Alphamab reloads with $60M to nurture the bispecific patch (Endpoints)
• Amicus, Penn expand gene therapy research agreement into five-year collaboration (Endpoints) (BioPharmaDive)
• Atara brings on Novartis vet to replace founder Ciechanover as chief (Endpoints)
• CVS, Express Scripts, and the Evolution of the PBM Business Model (Drug Channels)
• Little Cara steers through their first positive PhIII with a ‘breakthrough’ drug and a path to the FDA (Endpoints)
• As #ASCO19 looms, a top analyst showers some love — and blockbuster status — on Amgen’s KRAS killer (Endpoints)
• Former Purdue Pharma president was compared to Pablo Escobar in email from a friend (CNN)
• FDA Warns Montana Compounder Over Insanitary Conditions (FDANews-$)
• FDA Hits Texas Drug Facility for Oversight of Pilot/Exhibit Batches (FDANews-$)
• One year after OxyContin launched, Purdue Pharma execs applied to patent 'self-destructing' emails (ABC)
• The Future of Pharma: The Role Of Biotech Companies (Forbes)
• FDA Approves First NDA Under Real-Time Oncology Review Pilot (Focus)
• FDA Should Reassess Postmarket Trials for Cancer Drugs Approved via Accelerated Pathway, Researchers Say (Focus)
• Tech giants partner with universities like Stanford. They’re also hiring away star medical researchers (STAT)
• Indian Drugmaker to FDA: Dance Festival to Blame for Cleaning Lapses (Focus)
• Alex Trebek shares ‘mind-boggling’ pancreatic cancer update (STAT)
• Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) as a Result of a Sterility Test Failure (FDA)

• Imara Announces FDA Fast Track Designation for IMR-687 for the Treatment of Sickle Cell Disease (Press)
• Cadent Therapeutics Announces FDA Orphan Drug Designation for CAD-1883 for Spinocerebellar Ataxia (Press)
• Rejenevie Therapeutics Announces Start of Phase II Immune Restoration Treatment Clinical Trial (Press)
• RegeneRx Licensee Administers RGN-137 to First Patient in Phase 2 EB Clinical Trial (Press)

• IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices (Focus)
• CDRH Outlines Vision for Good Machine Learning Practices (Focus)
• AngioDynamics Sets Sights on Prostate Cancer with New IDE (MDDI)
• FDA’s Pre-Cert Program Enters its Testing Phase (FDA Law Blog)
• MediWound lands $21m extension from BARDA to support NexoBrid (MassDevice)
• Medtronic wins FDA nod for SelectSite catheter (MassDevice) (Press)
• FDA grants De Novo clearance to smartphone-controlled acute migraine-relief device (mobihealthnews)
• FDA Clears Two Hologic Vaginitis Assays (GenomeWeb) (Press)
• Leica Biosystems Receives FDA 510(k) Clearance to Market a Digital Pathology System for Primary Diagnosis (Press)
• Ansun Biopharma Announces First Patient Enrolled In Phase 3 Clinical Trial Evaluating DAS181 In Hospitalized, Immunocompromised Patients With Lower Respiratory Tract Parainfluenza Virus Infection (Press)
• Class I Recall for three Terumo devices (FDA 1, 2, 3)

• FDA Rolls Eyes At Drug Co.'s 'Financial Distress' Claim (Law360-$)
• Measles Outbreaks, Vaccine Hesitancy, and Federal Policy Options (CRS)
• House Vs. Senate Drug Pricing Bills: A Snapshot Of Differences (Pink Sheet-$)
• Republican Senators Prod FDA to Expand Parallel Track (FDA News-$)
• Cosmetics Industry Seeks FDA Recall Power Over Tainted Makeup (Bloomberg)
• Dark Web Provider Escapes Wrongful Death Drug Case (Drug & Device Law)
• A Comparison of U.S. and Japanese Patent Subject Matter Eligibility (Patent Docs)

• FDA Advisory Committee Calendar

• France Lifts Clinical Hold From AB Science’s Masitinib (Scrip-$)
• France to ban widely used crop fungicide over health concerns (Reuters)
• Theresa May failed to tackle “country’s biggest injustices”, says NHS (PharmaTimes)
• The Swedish Medical Products Agency Approves New Treatment Arm With Remygen and Alprazolam in Phase I/II Trial ReGenerate-1 (Press)
• Early access to medicines scheme (EAMS) scientific opinion: tafamidis for the treatment of transthyretin amyloidosis in adult patients with wild type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalization (MHRA)

• Tokyo District Court rules on Rituxan biosimilar (PharmaLetter-$)
• China-India joint summit discusses bilateral trade to improve pharma industry (PharmaBiz)
• Clean-up set to wipe out Vietnam’s small health supplement makers (Financial Times)

• Indian regulators unveil risk classifications for recently notified medical devices (Emergo)

• Revised GMP clearance fees take effect 1 July 2019 (TGA)