Recon: FDA Approves Two Paratek Antibiotics; Boston Pharma Licenses Eight Drugs from GSK, Novartis

• A go-go FDA is poised to break the all-time record on new drug approvals. Is this the new standard for biopharma success? (Endpoints)
• 2 Paratek antibiotics win FDA nods, with 1 slated for $500M in peak sales (Fierce) (Endpoints)
• Boston Pharmaceuticals supercharges pipeline with twin deals grabbing top cast-offs from GSK, Novartis (Endpoints) (Fierce)
• The biotech scorecard for the fourth quarter: 12 make-or-break industry events to watch (STAT)
• At NEJM, a change at the top offers a chance to reshape the world’s oldest medical journal (STAT)
• Memorial Sloan Kettering’s Chief Executive Resigns From Merck’s Board of Directors (ProPublica)
• Psychedelic Mushrooms Are Closer to Medicinal Use (It’s Not Just Your Imagination) (NYTimes)
• Why some people are worried about drug patent protections in the new NAFTA (Marketplace)
• The Republican rush to protect pre-existing conditions, hypothetically (Politico)
• Merck runs out of Parkinson’s disease drug Sinemet as manufacturing issues, forecasting miss lead to shortage (Fierce)
• Green light for acne drug Seysara in the US (PharmaTimes)
• Roche, Novartis grab FDA OK for new version of aging blockbuster Xolair (Fierce)
• Drug companies fear Democratic Congress (The Hill)

• UK alarm bells are ringing as a biotech cuts a few trial sites, fretting over Brexit’s impact on drug development (Endpoints) (Pharmafile)
• Lilly gets EMA nod for Verzenio in breast cancer (PMLive) (PhamaTimes)
• Preliminary NICE ‘no’ for Takeda’s Alunbrig (PharmaTimes)
• Yemen cholera outbreak accelerates to 10,000+ cases per week: WHO (Reuters)
• Ten die of MERS in Saudi Arabia among 32 cases in last three months: WHO (Reuters)
• With Hemlibra, Roche seeks to break into tight hemophilia circle (Reuters)
• Impatient patients turn to online 'buyers club' for new drugs (Reuters)
• In Australia, Cervical Cancer Could Soon Be Eliminated (NYTimes)
• How Capitalism Ruined China’s Health Care System (NYTimes)
• Hancock says UK genome service is now ‘rolling out’ (PMLive)
• EFPIA statement on European Parliament Plenary on HTA regulation (EFPIA)
• EFPIA’s vision to build a healthier future for Europe (EFPIA)

• Forty Seven adds Nobel winner Jim Allison to a dream team of scientific advisers (Endpoints)
• Kite adds to T-cell receptor platform with HiFiBiO deal (Fierce)
• Belldegrun and Chang groom their biotech unicorn Allogene for a monster $288M — or so — IPO (Endpoints)
• Pfizer Launches Nivestym At An Aggressive Discount To Other Filgrastim Products (SCRIP-$)
• FDA Offers New ‘cGMP Declarations’ That Could Fill US Gap In EU GMP Certificates (Pink Sheet-$)
• Ipsen Joins Biotechnology Innovation Organization (BIO) to Advance Growth and Innovation (Press)
• McCann Health taps Sam Taylor to head of GlaxoSmithKline pharma and consumer business (Fierce)
• Kala Pharmaceuticals Announces Pricing of Public Offering of 7,500,000 Shares of Common Stock (Press)
• Allogene IPO Could Be Year's Largest Biotech Listing On NASDAQ (BioCentury)
• PET Drugmaker Warned for Unclean Conditions and Bacterial Contamination (FDANews-$)
• Reputation on the (production) line: US, Germany and Japan rank as ‘tier one’ nations (BioPharmaReporter)
• Patients Give Doctors High Marks For Prescribing Antibiotics For Common Sniffles (NPR)
• Harpoon Therapeutics Announces Appointment of Natalie R. Sacks, M.D., as Chief Medical Officer (Press)
• Teva exec joins Rewind Therapeutics as CEO (PharmaLetter-$)

• Seattle Genetics' Adcetris tops chemo in Phase 3 lymphoma trial (BioPharmaDive) (Press)
• Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy (Press)
• Genentech takes aim at Biogen and Novartis, highlighting an early look at positive results for their oral SMA drug from PTC (Endpoints) (Press)
• Clovis' Rubraca pulls ahead of rivals in prostate cancer with 'breakthrough' nod (Fierce) (BioCentury) (Press) (Press)
• Gilead's FXR Agonist Among Nash Therapies Highlighted Ahead Of AASLD (BioCentury)
• Omeros' OMS721 Underwhelms In Phase II (BioCentury)
• Alnylam Submits Clinical Trial Authorization (CTA) Application for ALN-AAT02, an Investigational RNAi Therapeutic for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (Alpha-1 Liver Disease) (Press)
• Catabasis Pharmaceuticals Presents Data Supporting MRI T2 as a Potential Marker of Clinical Outcome in Duchenne Muscular Dystrophy at the World Muscle Society Congress (Press)

• GenMark Submits ePlex BCID Gram-Negative, Fungal Pathogen Panels for FDA Clearance (GenomeWeb)
• FDA Proposes Updates to the Special 510(k) Program (FDA Law Blog)
• Georgia Tech affiliate GCMI plans incubator for Israeli medtech startups (MassDevice)
• What Could Go Wrong If Designers Don’t Understand Manufacturing? (MDDI)
• Endologix soars on Q3 prelims beat, raised outlook (MassDevice)

• Fentanyl test strips lead to more caution among illicit drug users (Washington Post)
• Texas Court Smotes Church’s Promotion of Bad Medicine (Drug & Device Law)
• Consumers Seek Sanctions For Mylan In EpiPen Pricing Suit (Law360-$)
• Abbott, Distributor Settle 'Gray Market' Test Strip TM Fight (Law360-$)
• Pfizer, Hospira Urge Final Nix Of Suit Over Faulty Pumps (Law360-$)

• FDA Advisory Committee Calendar
• FDA and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast – 11-15 November 2018      

• Medicines: licensing time-based performance measures (MHRA)
• DiaSorin Receives CE Mark for Varicella-Zoster Virus Assay (GenomeWeb)
• Oxford University spin-off receives 'world-first' accreditation for vital signs measurement software (mobihealthnews)

• Ipca Labs subsidiary acquires 80% stake in Bayshore Pharmaceuticals for USD 10.28 mn (Economic Times)
• India’s first bio-bank for drug-resistant microbes starts operations, guidelines on sample collection in the works (PharmaBiz)
• Medical devices sector seeks price preference in public tenders to boost domestic manufacturing (PharmaBiz)
• Gujarat drug cos get CDSCO clearance on notices served for remedial measures (PharmaBiz)

• Moroccan widow turns her home into a shelter for cancer patients (Reuters)