Recon: Bayer to Cut 12,000 Jobs, Plans Sale of Animal and Consumer Health Business

• Merck raised prices five drugs including Keytruda in November (Reuters)
• How Scott Gottlieb is Wrong on the Gene Edited Baby Debacle (Harvard Bill of Health)
• Alkermes schizophrenia treatment meets main goals in late-stage study (Reuters) (STAT) (Endpoints)
• FDA approves Catalyst Pharma's rare disease drug (Reuters) (FDA)
• Astellas Pharma gets US nod for blood cancer treatment (Reuters) (Endpoints) (FDA) (Press)
• FDA approves first biosimilar to Roche cancer drug Rituxan (Reuters) (FDA) (Press)
• Once-a-day pills for combating HIV are a better deal than some people think (STAT)
• Catalyst Pharma’s LEMS drug Firdapse wins FDA nod, as regulators keep the approval engine running at record speed (Endpoints)
• Number Of U.S. Kids Who Don't Have Health Insurance Is On The Rise (NPR)
• Democrats Taking Key Leadership Jobs Have Pocketed Millions From Pharma (KHN)
• Conservative groups write letter opposing Trump move to lower drug prices (The Hill)
• Drug overdoses and suicides fuel drop in U.S. life expectancy (Politico) (Politico) (NBC)

• Bayer Cuts 12,000 Jobs, Plans Vet-Unit Exit as Suits Weigh (Bloomberg) (WSJ) (Financial Times) (Press)
• China Halts Work by Scientist Who Says He Edited Babies’ Genes (NYTimes) (STAT) (NBC)
• Google’s Parent Has a Plan to Eliminate Mosquitoes Worldwide (Bloomberg)
• Pharmaceutical corporations failing children with HIV (MSF)
• Gunfire, threats and curfews slow Congo's fight against Ebola (Reuters)
• Experts: Declare Ebola in Congo an International Health Emergency (Medpage) (NEJM)
• Biocartis partners with AstraZeneca on lung cancer diagnostics (Reuters)
• Brexit ‘could be an opportunity for UK clinical research’ (Fierce)
• Samsung BioLogics strikes back, filing lawsuit over criminal penalties imposed by Korean regulators (Fierce)
• MSD claims EU approval for two HIV products (PMLive)
• EU gives Bayer's Jivi the green light (PharmaTimes)
• Novartis' Gilenya scores paediatric EU approval for advanced relapsing-remitting MS (Pharmafile)
• Bayer’s Stivarga wins NICE backing for advanced liver cancer (PharmaTimes)
• NHS cracks down on low-priority prescriptions (PharmaTimes)

• Generations: Talent Dispersion in Biotechnology (LifeSciVC)
• Scientists create "mini placenta" organoids in a lab dish (Reuters)
• When Clinical Trials Are Marketing Ploys, Not Science (Forbes)
• Project Renewal: US FDA's Plan To Update Generic Cancer Drug Labels Depends On NDA Holders (Pink Sheet-$)
• Universal influenza vaccine candidate reduces transmission of virus best when given nasally in mice (FDA)
• JCR Launches the First Biosimilar Agalsidase Beta (Center for Biosimilars)
• First-line lung cancer: can Keytruda be stopped? (Evaluate)
• US FDA Likely Cannot Force Sponsors To Fund Opioid Prescribing Guideline Trials (Pink Sheet-$)
• Drug Shortages: Would Sponsors Admit Their Products Are Vulnerable? (Pink Sheet-$)
• LPAD Approval Pathway Is Not Saving Antimicrobial Development (Pink Sheet-$)
• Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (FDA)
• Spark Therapeutics adding 500 new jobs in Philadelphia (PharmaLetter)
• Industry Experts, Clinicians Seek Solutions to Drug Shortages (Medpage)
• German Drugmaker Cited for Cleaning Procedures (FDANews-$)
• Low sales, high cost: Melinta slashes HQ research staff as it struggles to grow antibiotics revenue (Endpoints)
• After a long, hard slog to the clinic, stem cell player ViaCyte fuels up with $105M for its next big attack on diabetes (Endpoints)
• The number of I/O cancer drugs in the clinic continues to swell at an explosive pace — offering new hope, fresh concerns (Endpoints)

• Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating JZP-258 for the Treatment of Idiopathic Hypersomnia (Press)
• European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients (Press)
• Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) to Treat Patients with Cystic Fibrosis Aged 12 to <24 months with Certain Mutations in the CFTR Gene (Press)
• Therachon is granted Orphan Drug Designation in the European Union for Apraglutide for the Treatment of Short Bowel Syndrome (Press)
• Tiziana Announces Initiation of Phase 1 Clinical Trial with Nasal Administration of Foralumab, a Fully Human Anti-Cluster Definition 3 Monoclonal Antibody (anti-CD3 mAb), in Healthy Volunteers (Press)
• ArQule to Host Analyst Call Highlighting Clinical Progress from Ongoing Phase 1 Study of Reversible BTK Inhibitor, ARQ 531, in Patients with Relapsed/Refractory Hematologic Malignancies (Press)

• FDA Relaxes UDI Compliance Deadlines in New Guidance Document (FDA Law Blog)
• ISO 14155 Third Edition Preview: Role of Risk Management in Clinical Investigations (Emergo)
• Invivoscribe CDx Assay Gets Expanded FDA Approval Alongside Astellas AML Drug (GenomeWeb)
• Amsel Medical wins FDA nod for Endo Occluder (MassDevice)
• ElectroCore wins cluster headache FDA 510(k) indication for GammaCore (MassDevice)
• Noninvasive vagus nerve stimulator receives FDA clearance for cluster headache prevention (mobihealthnews)
• Class 1 Device Recall QUADROXi Neonatal oxygenator (FDA)

• Patents on pot? U.S. lawsuit puts cannabis claims to the test (Reuters)
• HHS OIG Opinion Raises Questions On Free Drug Offers (Law360-$)
• Mylan Asks Supreme Court To Rein In 'Tactical' Drug Patenting (Law360-$)
• Full Fed. Circ. Asked To Skip 'Blocking Patent' Case (Law360-$)
• Eli Lilly Wins Stay In Eagle Antitrust Suit Amid Patent Fight (Law360-$)
• Personal Jurisdiction Wins Cases (Drug & Device Law)
• Lawsuit Accuses Gilead of Sitting on Safer HIV Drugs to Maximize Profit (FDANews-$)
• Mylan Pushes For Consumer Witnesses In Battle With Celgene (Law360-$)
• Med Tech Co. Seeks DC Circ. Review Of $400M Award Denial (Law360-$)
• Drug Co. Can’t Duck Opioid Questions In Pay-For-Delay Suit (Law360-$)
• FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan (FDA)

• FDA Advisory Committee Calendar
• Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee – 11 January 2019
• Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting – 16 January 2019
• Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting – 17 January 2019

• Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power. (MHRA)

• Varian receives China NMPA approval for cancer treatment system (Medical Design & Outsourcing)

• Government plans database of drugs to prevent use of similar brand names (Economic Times)
• GlaxoSmithKline taps Unilever as lead bidder in Indian Horlicks buyout: report (Fierce)

• Company will pay over $25,000 in fines for alleged importation of unapproved therapeutic goods (TGA)
• Boxed Warning guidance (TGA)
• Final decisions amending, or not amending, the current Poisons Standard, November 2018 (TGA)
• TGA presentation: Advertising Therapeutic Goods to consumers - Complaints handling (TGA)

• Niger closes UK charity's health centers, says they performed abortions (Reuters)

• Older drivers taking multiple medications could be at higher risk of accidents (Reuters)
• Online Cancer Information Is Often Unreliable (NYTimes)
• Cancer diagnosis tied to increased suicide risk (Reuters)
• Nancy Cappello, Breast Cancer Activist, Is Dead at 66 (NYTimes)