Recon: FDA Rejects Motif Bio Antibiotic; AstraZeneca Drops MedImmune Name in R&D Restructuring

• Biotech Hedge Fund Bailed on Drugmaker Before Its Depression Treatment Scored (Bloomberg)
• Pfizer still holds the lead in the erectile dysfunction market even as Viagra sales falter (CNBC)
• In rap video, Insys opioid salesmen boasted of their prowess (Boston Globe)
• Motif Bio’s turnaround quest for once-rejected antibiotic hits the CRL wall (Endpoints) (Fierce) (Press)
• Donated globally since 2005, Novartis’ flatworm treatment Egaten wins FDA nod — and a PRV (Endpoints) (Pharmafile) (BioPharmaDive)
• Robot Wars: $60B Intuitive Surgical Dominated Its Market For 20 Years. Now Rivals Like Alphabet Are Moving In. (Forbes)
• How the ‘Worst’ Launch in Pharma History Spurred Opioid Surge (Bloomberg)
• Pay Attention to This Little-Noticed Opioid Lawsuit in Oklahoma (Pew)
• E&C Leaders Seek FDA Briefing on Contaminated Sartans (Focus) (Bloomberg) (Economic Times)
• Ironwood to cut 35 more jobs as company split nears (BioPharmaDive)
• The 100 Leading Pioneers Of AI Drug Development (Forbes)
• Pain Patients to Congress: CDC's Opioid Guideline Is Hurting Us (Medpage)
• Two decades of data reveal overall increase in pain, opioid use among US adults (NIH)
• Merck to further study Keytruda in prostate cancer after early success (Reuters) (Press)
• Can California Beat The Federal Government In Lowering Drug Prices? (KHN)
• A slice of the health care industry is disappointing Wall Street (Axios)

• AstraZeneca Turns a Corner After a Decade of Struggle (WSJ) (Financial Times)
• AstraZeneca sweeps away the MedImmune name as CEO Soriot restructures R&D (Endpoints)
• Eagle and Mystic lead AstraZeneca’s cancer clear out (Fierce)
• No-deal Brexit could see UK locked out of EU infectious disease surveillance data, chief medical officer warns (Pharmaceutical Journal)
• Nearly 1,000 Madagascar children dead of measles since October: WHO (Reuters)
• Precious antibiotics still being used to boost animal growth: OIE (Reuters)
• EU-Singapore Trade Pact Nears Entry Into Force After Long Delay (Bloomberg)
• Uncertainties around generic drugs leave cloud over Indivior’s future (Financial Times)
• Novartis first to benefit from NICE advice on ‘patient preference’ (PMLive) (PharmaTimes)
• Turkey's pharmacists struggling to obtain medicines: association (Reuters)
• In HKEX’s first test in 2019, CStone seeks up to $304M in IPO fortune (Endpoints)
• Novartis inks 10-target antibody discovery deal with AbCellera (Fierce) (PharmaTimes)
• Korean biotechs snatch US stem cell manufacturing facility (Fierce)
• Teva stock tumbles as it warns of ‘trough’ in 2019 (Financial Times)
• Johnson & Johnson, Takeda and Evotec join The Dementia Consortium (PharmaTimes)

• I’m a cancer patient. The FDA’s ‘wait and see’ approach is not helping. (Washington Post)
• CDER Proposes Program to Create Voluntary Pharmaceutical Quality Standards (Focus)
• FDA Names New Office of Generic Drugs Director (Focus)
• Study: Patent Term Restoration Extends Drug Patents by About 3 Years (Focus)
• Drug company payments for consulting and speaking influence oncologists’ prescribing (STAT)
• Jazz set to lose rights to Erwinaze after partner cancels deal (BioPharmaDive)
• Certain drugs, supplements may improve sperm health (Reuters)
• TCR²’s IPO Raises $75M to Bring Cancer Cell Therapy to Solid Tumors (Xconomy)
• Risky Antibiotics Still Widely Prescribed at Hospital Discharge (Medpage)
• David de Graaf has a new gig, a new idea and a new startup — hunting some new money (Endpoints)
• All A-Board (LifeSciVC)
• The Fight Against Superbugs: 5 Priorities for 2019 (Pew)
• Drugmakers Seek Clarity on FDA’s Plan for Real-World Evidence in Trials (FDANews-$)
• FDA reopens comment period on real-world evidence program (FDA)
• Ramaswamy’s Axovant whips up a CNS spinoff with a $530M deal and a syndicate of supporters (Endpoints)
• Collaboration And Pay For Performance Deals – The Way To Pay for One-Off Treatments (Pink Sheet-$)
• DBV estimates peanut allergy drug submission in Q3, but it may be too little too late in race with Aimmune (Endpoints)
• Using ‘decoy’ platelets to stem blood clots and cancer metastases (Fierce)
• AstraZeneca drops an OX40 cancer drug candidate in Q4 pipeline cleanup (Endpoints)
• IBM Watson Health announces slew of AI-based research partnership deals (MassDevice)

• Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53 (Press)
• Antipsychotic from Lundbeck, Otsuka flops again in PhIII trials — this time in bipolar patients (Endpoints)
• Ocugen wins orphan drug status for ocular gene therapy (Drug Delivery)
• Positive Phase 3 Study for Tezacaftor/Ivacaftor Combination in Children Aged 6-11 Years with Cystic Fibrosis Supports European Medicines Agency Submission (Press)
• Omeros Corporation Streamlines Path to Biologics License Application for OMS721 in HSCT-TMA Following Meeting with FDA (Press)
• RDD Pharma Receives Fast Track Designation from FDA for RDD-0315 for Treatment of Fecal Incontinence in Spinal Cord Injury Patients (Press)
• Verastem Oncology Announces Publication of the Phase 2 DYNAMO Study Results in Indolent Non-Hodgkin Lymphoma in the Journal of Clinical Oncology (Press)
• Advaxis Announces Enrollment of the First Patient in its Phase 1/2 Trial for ADXS-HOT in the Treatment of Non-Small Cell Lung Cancer (Press)
• Trovagene Presents Update on Phase 2 Study of Onvansertib in Combination with Zytiga in Patients with mCRPC at ASCO-GU Conference (Press)
• Innovent Announces First Patient Dosed in a Phase I Clinical Trial of an Anti-OX40 Antibody (Press)

• Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh (Focus) (Medpage)
• Becton Dickinson wins FDA 510(k) for Wavelinq 4F endoAVF system (MassDevice)
• Fujirebio Diagnostics Receives FDA Breakthrough Device Designation for Lumipulse® G β-Amyloid Ratio (1-42/1-40) Quantitative In Vitro Diagnostic Test (Press)
• Corindus Announces FDA Submission for Neurovascular Intervention Indication for CorPath® GRX Vascular Robotic System (Press)
• FDA Clears Safe Medical Design’s Innovative New Urinary Catheter Design Aimed At Increased Patient Safety (Press)
• Medtronic and Medical University of South Carolina Partner to Improve Patient Outcomes (Press)
• Bausch + Lomb wins FDA 510(k) for contact lens coating (MassDevice)
• Would a NuVasive Deal Make Sense for Smith & Nephew? (MDDI)
• GI Dynamics wins IRB approval for pivotal U.S. EndoBarrier trial (MassDevice)

• Dems offer smaller step toward ‘Medicare for all' (The Hill)
• Golden Introduces New Bill to Stop Drug Companies’ Unfair Price Hikes, Address Rising Rx Costs in America (Golden)
• AAM Welcomes Re-Introduction of the PACED Act (AAM)
• Hackers are stealing millions of medical records – and selling them on the dark web (CBS)
• DC Firm Helped Ranbaxy Avoid FDA Scrutiny, RICO Suit Says (Law360-$)
• Direct To Prescriber Off-Label Communication Ethical Under New AdvaMed Guidelines (Drug & Device Law)
• Innovative And Ineligible: Diagnostic Patents At Fed. Circ. (Law360-$)
• DOJ Flexes New Muscles In Opioid Fight (Law360-$)
• J&J Talc Supplier Seeks Ch. 11 Amid Asbestos Suit Tidal Wave (Law360-$)

• FDA Advisory Committee Calendar

• EMA Checklist To Help Companies Submit 'First Time Right' MAAs (Pink Sheet-$)
• Hologic’s Aptima HIV-1 Assay Receives Dual Claim CE Marking (GenomeWeb)

• Rituxan Biosimilar Grabs 30% Volume Share in Just 1 Year; Sales Expected to Double in 2019 (PharmaJapan)
• Interview: Janssen Builds Japan Specialty Interests But Wants Ongoing Policy Debate (Scrip-$)
• Japan Firms Up Cost-Effectiveness Plans As Industry Concerns Linger (Pink Sheet-$)
• Bioneer HIV-1 Dx Kit Gets Korea FDA Approval (GenomeWeb)

• Bureaucratic resistance may spoil opportunity to set up national rare disease patient registry; proposal to create Census-linked data hits wall (PharmaBiz)
• CDSCO urges medical device cos to register products by April 2020 in Sugam portal for timely approvals (PharmaBiz)
• Supreme Court to hear Centre’s petition against Delhi High Court order on oxytocin today (PharmaBiz)

• Bugs Vs. Superbugs: Insects Offer Promise In Fight Against Antibiotic Resistance (NPR)
• What happened to bird flu? How a major threat to human health faded from view (STAT)
• Can Big Science Be Too Big? (NYTimes)