Recon: Roche Completes Spark Acquisition; FDA Approves Expanded Indication for Pfizer’s Xtandi

• FDA approves expanded label for Pfizer’s prostate cancer drug Xtandi (CNBC) (Endpoints) (Press)
• Alnylam gene-silencing therapy succeeds in late-stage study (STAT) (Reuters) (Endpoints) (Press)
• FDA’s staff review offers bleak assessment of Epizyme’s tazemetostat (Endpoints) (Fierce)
• Adamas drug to help MS patients walk does not show expected clinical benefit (Reuters)
• Amylyx drug helps slow ALS progression in mid-stage study (Reuters) (WSJ)
• Biohaven Pharma says treatment for acute migraine succeeds in study (Reuters) (Endpoints)
• GSK seeks US approval for rival to J&J's multiple myeloma drug (Reuters) (BioPharmaDive) (Endpoints) (Evaluate)
• Purdue Pharma Payments to Sackler Family Soared Amid Opioid Crisis (NYTimes) (Reuters)
• Purdue, maker of OxyContin, quietly splits ways with PhRMA as it pulls back from lobbying (STAT)
• 82 Professors Call on Court to Support FTC Decision in Pay-for-Delay Case (Focus)
• Pharma catches a break in year-end spending bill (Politico)

• Roche Completes Spark Acquisition After FTC, CMA Approval (BioPharmaDive) (Endpoints)
• Inside Astellas' $3B Audentes gene therapy acquisition: coded messages, a bidding war and $77M for the CEO (Endpoints)
• EU’s Pharmacovigilance System: A ‘New Era Of Safety & Transparency’ (Pink Sheet-$) (EMA)
• NICE reverses previous decision to recommend Vifor Pharma's Veltassa for NHS treatment of hyperkalaemia (Pharmafile)
• Irish haemophilia A patients to get continued access to Sobi’s extended half-life factor replacement therapy (Pharmafile)
• European Parliament Adopts Second Round of MDR, IVDR Corrigenda (Focus)

• In novel partnership with cancer group, biotech venture firm doles out grants for research (STAT)
• Startup targeting DNA repeats in Huntington’s and other diseases debuts with $59 million (STAT)
• Seer raises $55M as proteomics approaches prime time in disease detection, drug development (Endpoints)
• Eli Lilly spotlights early oncology in first pipeline review since R&D shift (Endpoints)
• BCMA programs begin to find their niches (BioCentury)
• Leveraging real-world data to assess the promise of CAR Ts, Dutch style (BioCentury)
• Aspen’s debut reveals first cell therapy investment by Domain (BioCentury)
• Bankrupt uBiome preliminarily sells patents for 1% of the poop-testing startup’s original valuation (STAT)
• How Novartis' cancer drug Tasigna restores critical dopamine that's lost to Parkinson's disease (Fierce)
• Kyn to Ikena: The Art and Science of Rebranding (LifeSciVC)
• What unifies Huntington's, spinocerebellar ataxia and myotonic dystrophy? Ness Bermingham's new startup looks to drug that (Endpoints)
• Testimony About FDA’s Foreign Drug Establishment Inspection Program: GAO and FDA See Things Differently but Both Would Like to See a Fuller Glass (FDA Law Blog)

• NIH launches first US clinical trial of patient-derived stem cell therapy to replace dying cells in retina (NIH)
• Versus Vertex, Proteostasis' triplet CF data fall short, wilting stock (Endpoints)
• Dicerna™ Receives Orphan Drug Designation From European Commission for DCR-A1AT for Treatment of Congenital Alpha-1 Antitrypsin Deficiency (Press)
• PharmaMar files for FDA approval of small cell lung cancer drug (Fierce) (Press)
• Eiger Initiates Rolling Submission of New Drug Application (NDA) with FDA for Lonafarnib for Treatment of Progeria and Progeroid Laminopathies (Press)
• Positive results reaffirm plans to advance ATL1102 for DMD to Phase IIb trial (Press)
• First-Ever Treatment for Rare, Rapid-Aging Disease Progeria Submitted in New Drug Application to the FDA (Press)
• TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure (Press)
• Herantis Pharma Plc Completes Patient Recruitment and Treatment in Phase 2 AdeLE Trial in Breast Cancer Associated Lymphedema (Press)
• ImmunoGen Announces Accelerated Approval Pathway for Mirvetuximab Soravtansine in Ovarian Cancer (Press)
• Akero Therapeutics Completes Enrollment in Phase 2a Study in NASH (Press)

• Roche Applies CE Mark to Zika Screening Test (GenomeWeb)
• FDA Wants to End Quarterly Reporting of Device Decisions (Focus)
• Medtronic pain pump recall deemed Class I (MassDevice)
• B. Braun Medical names new chairman & CEO (MassDevice)
• FemmePharma Granted US FDA 510(k) Clearance for Satisfaite™ (Press)

• Device Tax Repeal, CREATES Added to Government Spending Bills (Focus)
• Strict Vaccine Law Stumbles in N.J. Legislature (NYTimes)
• Coming today: New organ donation rules (Politico) (HHS)
• Takeaways from a biotech CEO on the House’s passage of H.R. 3 (STAT)
• Fed. Circ. Backs Amgen's $70M Patent Win Over Epogen (Law360-$)
• FDA’s “Appropriation Fate” Is Evaluated on a Daily Basis (Alliance for a Stronger FDA)
• Lawmakers propose 7% increase in NIH funding (Fierce)
• Surprising Swings In Momentum For Legislation On Surprise Medical Bills (KHN)
• Bayer asks US appeals court to reverse $25 million Roundup verdict (Reuters)
• US government extends deadline to sign up for Obamacare insurance plans (Reuters)
• State appeals opioid verdict claiming $465 million award is not enough (The Oklahoman)
• Bausch Health plans $1.21 B settlement over stock plunge (AP) (Law360-$)
• Athena Diagnostics Seeks Supreme Court Review of Athena Diagnostics v. Mayo Collaborative Services (Patent Docs)
• It’s All About Home (Drug & Device Law)
• FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway (FDA)

• FDA Advisory Committee Calendar

• McKesson and Walgreens join wholesaling efforts in Germany (Fierce)
• Maintaining Regulatory Impacts – EU IVD Regulation (Medtech Europe)

• Indian pharma seeing record VC investment and significant deal-making (PharmaLetter-$)
• Draft Amendment Rules for regulation of medical devices in India (Lexology)

• Reforms to the generic medicine market authorisation process: implementation update (TGA)

• Declining numbers of Americans have a primary care provider (Reuters)
• Valley Fever Cases Climb In California’s Central Valley — And Beyond (KHN)