Recon: Drugmakers Kick off 2020 With Hundreds of US Price Increases

• Drugmakers from Pfizer to GSK to hike U.S. prices on over 200 drugs (Reuters 1, 2, 3)
• Novo Nordisk to offer free insulin to US patients in immediate need (Reuters)
• Antibiotic Makers Struggle, Hurting War on Superbugs (WSJ) (NYTimes)
• Pfizer, Merck KGaA show immunotherapy's survival benefit in bladder cancer (BioPharmaDive) (Endpoints)
• Incyte takes a beating as a key PhIII study flops in their latest painful setback — blockbuster hopes crushed (Endpoints) (Press)
• AstraZeneca, Merck score win with Lynparza approval for pancreatic cancer (Reuters)
• Illumina and Pacific Biosciences call off merger (Financial Times) (MedtechDive) (Endpoints)
• California Pay-For-Delay Ban Headed To 9th Circ. (Law360-$) (STAT)
• Trump touted a new antidepressant as a solution for veterans. Only 15 have been treated (STAT)

• Canadian parents of babies with rare deadly disease look to Novartis treatment lottery (The Globe and Mail)
• 'I don't want to regress': Patients, doctors divided on Alberta's move to change biologic drug coverage (CBC)
• Additional evidence needed to assess histology-independent cancer drugs says paper co-authored by NICE staff (NICE)
• Drug developers take fresh aim at 'guided-missile' cancer drugs (Reuters)
• NICE rules against the use of Akcea’s Waylivra in the NHS (Pharmafile) (PMLive) (Endpoints)
• KRAS craze sees Merck put $2.5B biobucks down for Taiho, Astex licensing deal (Fierce) (Endpoints)
• Despite secret discount, Roche's Tecentriq hits NICE roadblock in small-cell lung cancer (Fierce)
• GSK divests travel vaccines to Bavarian Nordic as part of strategic refocus (PMLive)
• Roche dives deeper into gene therapy with $1.15 billion Sarepta licensing deal (Reuters) (Press)
• Chinese authorities say viral pneumonia outbreak is not SARS, MERS or bird flu (Reuters) (WHO)
• China approves home-grown vaccines, offering alternative to global drugmakers' products (Reuters)
• BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim (Endpoints)
• China’s CF PharmTech Raises $90M to Advance Respiratory Drug Development (Xconomy) (Endpoints)
• AstraZeneca’s drug Lokelma approved in China (Fierce)

• Century-old TB vaccine may work better if given in a new way (AP) (NYTimes)
• Keytruda's head and neck approvals reveal regulatory divergence (Evaluate)
• Medical breakthroughs, looser FDA made biotech stocks one of the decade’s best investments (CNBC)
• FDA rushed to approve new drugs in 2019, sometimes way ahead of schedule. Could that be dangerous? (Endpoints)
• A Decade Marked By Outrage Over Drug Prices (NPR)
• As Tens of Thousands Died, F.D.A. Failed to Police Opioids (NYTimes)
• 3 drug pricing policy experiments to watch in 2020 (STAT)
• After Audentes buy, acquisitive Astellas snaps up CAR-T biotech (Fierce) (Press)
• The first biotech IPO of the new decade has landed — and of course it's another cancer drug developer (Endpoints)
• Offering much needed relief for Woodford-associated funds, sequencing unicorn Oxford Nanopore raises $105.9M in new cash (Endpoints)
• Combination drugs that fuse multiple medications can have shocking price tag (NBC)
• Lab finds NDMA in Zantac can develop during storage (Fierce)
• As questions swirl around lead drug, FibroGen (and AstraZeneca) find a new champion from Big Pharma (Endpoints)
• FDA Faces Challenges Recruiting Scientists, Analysts (Heartland)
• Correvio's heart drug fails to get FDA approval (Reuters)
• Allergan's acute migraine treatment wins U.S. FDA approval (Reuters) (FDA)
• Eisai Inc announces U.S. approval for insomnia drug (Reuters)
• Israel's IceCure says gets FDA nod to treat tumors in liver, kidney (Reuters)
• FDA approves Intra-Cellullar's schizophrenia drug, shares soar 85% (Reuters)
• FDA approves first generic of Bristol-Myers, Pfizer's blood thinner Eliquis (Reuters) (FDA)
• Moderna CEO Bancel acknowledges a setback, but stays focused on an upbeat assessment of 2019 (Endpoints)
• Pathogen Genomics in Public Health (NEJM)
• Gender Parity in Clinical PrEP Trials (NEJM)
• ‘Off-the-shelf’ allogeneic CAR T cells: development and challenges (Nature)
• Novo Holdings tweaks fund to take antibiotics deeper into the clinic (Fierce)
• Evotec CEO Discusses Ways to Make Drug R&D Faster and Better (Xconomy)
• Green Valley’s algae-based Alzheimer’s drug to undergo global clinical trials  (PMLive)
• US FDA Tiptoes Further Into Off-Label Use Discussions With CURE ID App (Pink Sheet-$)
• CDMO WuXi STA opens manufacturing facility to produce oligonucleotides (Fierce)
• After midstage flop, Janssen says thanks but no thanks to Provention Bio drug (Fierce) (Endpoints)
• Site-Agnostic Cancer Drugs: HTAs Will Need Post-Approval Data (Pink Sheet-$)
• Year in Review: The Top-Five U.S. Biosimilar Market Developments of 2019 (Big Molecule Watch)
• Personalized Medicine in 2019: Options Increasing But Are They Reaching Patients? (GenomeWeb)
• U.S. diabetes patients turn to 'black market' for medications, supplies (Reuters)
• Antibiotics maker Melinta files for Chapter 11 bankruptcy (Reuters)
• Sol-Gel acne cream reduces marks in late-stage studies, shares soar (Reuters)
• Opinion: Congress should act to allow a ban on fentanyl indefinitely (Washington Post)
• I spent half my life on antidepressants. Today, I’m off the medication and feel all right. (Washington Post)
• Mavidon Issues Voluntary Worldwide Recall of all Manufactured Products Due to Burkholderia cepacia Contamination (FDA)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations to Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood and Blood Components; Agency Guidance (FDA)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Advisory Committee Nomination Applications (FDA)
• Findings of Research Misconduct (FDA)

• AstraZeneca's Farxiga nabs FDA priority review for pioneering heart failure nod (Fierce) (Press)
• Durect shares rocked by midstage psoriasis flop, shifts focus to liver disease (Fierce) (Press)
• BioMarin Announces New England Journal of Medicine Publishes 3 Years of Follow-up Data in Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A (Press)
• Gamida Cell Announces Completion of Patient Enrollment in Ongoing Phase 3 Clinical Study of Omidubicel (Press)
• Precigen Receives FDA Orphan Drug Designation for PRGN-3006 UltraCAR-T™ in Patients with Acute Myeloid Leukemia (AML) (Press)
• Biostage Provides Update on FDA Investigational New Drug Application for its Lead Product Candidate Cellspan™ Esophageal Implant (Press)
• WuXi Biologics Congratulates OncoImmune on FDA Clearance of IND Application for Next Generation anti-CTLA-4 Antibody ONC-392 (Presss)
• Wave’s Huntington’s Drug Disappoints in Clinical Trial, Stock Sinks (Xconomy)
• Novan crushed by phase 3 failures of antiviral gel (Fierce)
• Trial failure keeps Incyte searching for its next act (BioPharmaDive)
• BeiGene bags option on Leap cancer drug, requests PD-1 combination trial (Fierce)
• FDA approves Fiasp® for treatment of children with diabetes (Press)

• US safety monitoring program for lifesaving devices may not be adequate (Reuters)
• A CRISPR Path to Cutting-Edge Materials (NEJM)
• FDA creates best practices for combination product developers (MedtechDive) (FDA)
• Medtech manufacturing lags pharma in emerging markets, McKinsey report says (MedtechDive)
• FDA finalizes exemptions for certain devices from 510(k) review (MedtechDive)
• Terumo subsidiary gains FDA nod for aneurysm flow diverter (MedtechDive)
• Industry, doctors, patients diverge on FDA outline for breast implant labels (MedtechDive)
• Simplified devices, pharmacy access among 2020 catalysts for diabetes tech: analysts (MedtechDive)
• Avita Medical wins FDA investigational device exemption approval for Recell System for vitiligo (MassDevice)
• Applied BioCode Receives FDA 510(k) Clearance for Syndromic Respiratory Pathogen Panel (Press)
• PhotoniCare wins FDA nod for imaging tech to spot ear infections (MassDevice)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System (FDA)

• FDA Plans to Ban Most E-Cigarette Flavors but Menthol (NYTimes)
• Year in Review: Top Five Legal Developments of 2019 Impacting Biosimilars (Big Molecule Watch)
• Legal Developments to Keep an Eye Out for in 2020 (Big Molecule Watch)
• 'U snooze u lose': Judgement day for $100M biotech insider trading scheme looms as son of former Ariad director stands trial (Endpoints)
• Ranbaxy Wants 1st Circ. To Settle Generics Antitrust Question (Law360-$)
• PhRMA Challenges Oregon Drug Pricing Transparency Laws (FDA Law Blog)
• Allergan signs $750 million settlement with purchasers of Alzheimer's drug Namenda (Reuters)
• Ironwood and Allergan Announce Settlement Resolving LINZESS (linaclotide) Patent Litigation (Press)
• U.S. government says verdict in Bayer's Roundup case should be reversed (Reuters)
• Pentagon Warns Military Personnel Against At-Home DNA Tests (NYTimes)
• Nevada prisoners denied hepatitis C treatment sue the state (NBC)
• Democrats Ask Supreme Court for Quick Decision on Obamacare (NYTimes)
• Reporting Adverse Events for Cannabis to the FDA (NEJM)
• Washington State Latest To Target J&J Over Opioid Epidemic (Law360-$)
• Medtronic Gets Patient's 'Defective' Pump Suit Trimmed (Law360-$)
• Cancer Treatment Maker Sues Over Alleged 'Copycat' Device (Law360-$)

• FDA Advisory Committee Calendar
• Quality Control: Stopping infections before they happen through safer endoscope reprocessing – 9 January 2020

• EU Drug Shortage Network Pilot Moves Into Second Phase (Pink Sheet-$)
• Sandoz opens new UK HQ (PharmaTimes)
• UK looks to shake up trial, medicines regulation amid Brexit (Fierce)
• MHRA expands approval of Dysport for symptomatic treatment of focal spasticity of the upper limbs in paediatric cerebral palsy (Pharmafile)
• Notified bodies MedCert, BSI gain new EU MDR and IVDR designations (MedtechDive)
• Researchers unable to identify batches of biologic drugs from 85% of Yellow Card reports (Pharmaceutical Journal)

• Chinese court sentences 'gene-editing' scientist to three years in prison (Reuters)
• MHLW to Beef Up GMP Inspections at API Manufacturing Sites in Asia from FY2020 in Response to Series of Supply Disruptions (PharmaJapan)
• MHLW Revises Safety Guidance on FIH Studies Following Death of Subject (PharmaJapan)
• Gene And Cell Therapies In Asia: Can China Deliver Despite Murky Regulations? (Pink Sheet-$)
• International Mutual Inspection Recognition Expands with ASEAN Accrediting Philippines Using PIC/S Criteria (IPQ)
• China regulator approves imports of J&J's Tremfya (Reuters)
• Japanese Regulator Approves Foundation Medicine CDx for Roche's Rozlytrek in Lung Cancer (GenomeWeb)

• Department of Pharmaceutical asks industry to regulate promotional practices (Economic Times)
• 2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector (Economic Times)
• Zydus Cadila in talks to sell two units for Rs 1,200 crore (Economic Times)
• Johnson & Johnson faces criminal charges in faulty hip implants case (Economic Times)
• GST profiteering: Rs 230-crore penalty on Johnson & Johnson (Economic Times)
• Aurobindo Pharma Inc recalls Mirtazapine tablets in US (Economic Times)
• Dr Reddy's launches generic hypotensive injection in US(Economic Times)

• Consultation: Proposed amendments to the Poisons Standard - Joint ACCS/ACMS meetings, March 2020 (TGA)
• Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project (TGA)
• Faecal Microbiota Transplant (FMT) product regulation (TGA)
• Direction about advertisements: Cat Media Pty Ltd (TGA)

• Brazilian Regulator Sets New Drug Registration Records (Pink Sheet-$)
• Countries implementing about half of WHO recommendations (Reuters)
• InterCure gets Israel's first imported medical cannabis shipment (Reuters)

• Study finds Google system could improve breast cancer detection (Reuters)
• The Decade In Global Health: New Drugs, Faster Trials, Social Media To The Rescue (NPR)