Recon: Novartis Acquires IFM Subsidiary in $1.6B Deal

• Novartis acquires Boston-based IFM Tre for work on drugs to modify the immune system (STAT) (Reuters) (Endpoints) (LifeSciVC)
• Pfizer biotech spinout nabs $125M megaround as Bain-backed syndicate bets on its late-stage game plan (Endpoints)
• Purdue Pharma’s newly created subsidiaries raise questions over attempts to shield assets from bankruptcy (STAT)
• Still hunting a blockbuster, Merck KGaA scores a win in the FDA approval column — more than 13 years in the making (Endpoints) (Press)
• Activist Starboard drops out of Celgene fight as proxy firms back Bristol-Myers bid (CNBC) (Endpoints) (Press)
• Settlement set to sling Soon-Shiong out of biotech investment (Fierce)
• US moves to toss Gilead whistleblower lawsuit over HIV drugs (Reuters)
• OxyContin-Maker Owner Maligned Opioid Addicts, Suit Says (WSJ) (NYTimes)
• Outgoing FDA chief Scott Gottlieb gets personal about leaving 'the best job' he's ever had (CNBC)
• How Democrats will message on health care this week (Politico)

• The IVD industry is undergoing significant change. Join BSI experts at their In-Vitro Diagnostic Regulation Workshop to learn about the most significant changes to the European Regulatory and Compliance Expectations for CE marking. Topics such as an IVDR Overview including Classification and Grouping Devices, interacting with the Notified Body, Technical Documentation Requirements, New Requirements for Performance Evaluation and Using the Remaining Transition Period Effectively will be covered. Register here.

• Cambridge fund raises more than $196M in the UK’s heftiest 2019 funding round (Endpoints) (Financial Times)
• China expands curbs on fentanyl, blames US for its abuse (Reuters)
• Congo registers record 15 new Ebola cases in one day (Reuters)
• Ebola treatment center in Congo reopens after attack (Reuters)
• Aurobindo Pharma, Lupin recall drugs in US market (Economic Times)
• Merck’s Keytruda wins first checkpoint inhibitor lung cancer approval in China; Puma sells rights to Nerlynx in Europe, parts of Africa for $60M upfront (Endpoints)
• AstraZeneca: capital remedy (Financial Times)
• French healthcare system 'should not fund homeopathy' (The Guardian)

• Maturing Ironwood is spinning off Cyclerion, its edgy, risk-taking kid brother (STAT)
• Arteaus’ Final Chapter: Monetization Of The Emgality Royalties (LifeSciVC) (Endpoints)
• Pfizer, Novartis-backed British biotech Artios nabs Eli Lilly, AstraZeneca R&D veteran (Fierce)
• As Merck Research Laboratories moves into new facility, 20 staffers get the ax (Fierce)
• Can genetic testing help doctors better prescribe antidepressants? There’s quite a debate. (Washington Post)
• Immune System Therapy Shows Wider Promise Against Cancer (AP)
• When the ‘real thing’ becomes a mirage: How patients in Alzheimer’s trials are coping with the treatment’s failure (STAT)
• AACR roundup: Checkpoint cocktails score early successes as Roche’s triple shows high response rate in frontline triple negative breast cancer (Endpoints)
• AACR: Little Apexigen steals the show with their CD40/Opdivo cocktail as AACR gets underway (Endpoints)
• AACR: Bay Area biotech bets on antibodies armed with immuno-stimulant to fight checkpoint-resistant cancers (Endpoints)
• Charles River Labs cuts jobs as it closes San Diego site (Fierce)
• Teva Women's Health, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications (FDA)
• FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals (FDA)
• Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket (FDA)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness (FDA)
• Training Program for Regulatory Project Managers; Information Available to Industry (FDA)

• FDA label expansion for UCB's Cimzia (PharmaTimes)
• Roche’s ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial (Press)
• Luye Submits NDA For Schizophrenia, Bipolar Disorder Therapy (BioCentury)
• FDA Approves TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Supplemental New Drug Application (sNDA) to include data for the Reduction of COPD Exacerbations and Hospitalizations (Press)
• Puma Biotechnology and Pierre Fabre Enter into Exclusive License Agreement to Develop and Commercialize NERLYNX® (neratinib) in Europe (Press)
• Syndax Pharmaceuticals Presents Updated Phase 2 Data from ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab) at the American Association for Cancer Research 2019 Annual Meeting (Press)
• Recida Therapeutics Announces the Initiation of a Phase I Clinical Trial of RC-01, a Novel LpxC Inhibitor (Press)
• BlackThorn Therapeutics Announces Positive Phase 1 Results for Its Selective KOR Antagonist, BTRX-335140 (Press)
• PellePharm Initiates Pivotal Phase 3 Clinical Trial of Patidegib Topical Gel in Patients with Gorlin Syndrome (Press)
• Biohaven Enrolls First Patient in Phase 2/3 Trial of BHV-3500, Third-Generation CGRP Receptor Antagonist, for the Acute Treatment of Migraine (Press)
• Poxel Initiates Phase 2a Program for PXL770, a Direct AMPK Activator for the Treatment of NASH (Press)
• Forbius’ AVID100, a Novel Anti-EGFR ADC, Reports Positive Phase 1 Data at AACR: Exceptionally High RP2D Established, Phase 2 in SCCHN and sqNSCLC Ongoing (Press)
• Celularity Announces Results of Phase 1 Studies of PNK-007, an Allogeneic, Off-the-Shelf, Placental-Derived Cell Therapy, at AACR Annual Meeting 2019 (Press)
• Selumetinib Granted US Breakthrough Therapy Designation in Neurofibromatosis Type 1 (Press)
• Northern Biologics Reports Initial Phase I Data for MSC-1 at AACR (Press)
• Preliminary Data from Phase 1 Study Evaluating ADXS-NEO Suggest Rapid Immunogenicity and Clinical Activity (Press)

• Contact lenses that reduce eye itch may become a reality (Reuters)
• FDA Proposes Radiological Health Deregulatory Action (Focus)
• Smith & Nephew to acquire patient monitor dev Leaf Healthcare (MassDevice)
• Philips wins $450m DoD patient monitor supply contract (MassDevice)
• Intellirod Spine Receives First-Ever Spine FDA De Novo Approval (Press)
• AngioDynamics Receives FDA Approval to Initiate NanoKnife® DIRECT Clinical Study for the Treatment of Stage III Pancreatic Cancer (Press)
• GDPR and human factors studies for medical devices: Key issues for manufacturers and sponsors (Emergo)
• FDA Classifies IVDs for Bacillus Detection (Focus) (FDA)
• Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems (FDA)

• Fresenius to Pay $231M to Resolve Foreign Bribery Charges (Focus)
• Fresenius Medical Care says US settlement will not affect 2019, 2020 results (Reuters)
• Pharma spends big as Massachusetts lawmakers review drug-pricing bills (Fierce)
• Why The Latest Fentanyl Surge Is Hitting Some Communities Harder Than Others (NPR)
• Bennet, Kaine set to introduce ‘Medicare X’ plan to expand health care (Politico)
• In Blow to Trump, Judge Blocks Health Care Law ‘End Run’ (NYTimes)
• Collins urges Barr not to work to kill Obamacare (Politico)
• Five major court battles over Trump's health agenda (The Hill)
• Feds Slam Pharma Execs' Bid To Void Kickback Convictions (Law360-$)
• A Test For Avoiding “Loose and Spurious” Forms of General Personal Jurisdiction After BMS (Drug & Device Law)
• Teva Wins Patent Case Related to Orexo Opioid-Treatment Drug (Bloomberg)
• DC to distribute 76K anti-overdose drug kits by fall 2019 (Washington Post)
• Insys Therapeutics Pushed Opioid With Bribes And Lies, Prosecutors Say (NPR)
• Scott Bill Would Tie US Drug Prices To Lowest In Industrialized NATIONS (BioCentury)
• Supreme Court rebuffs anti-abortion activists in Planned Parenthood suit (Reuters)
• Medtronic seeks another bite at the apple in $24m patent loss to spine doc inventor (MassDevice)

• FDA Advisory Committee Calendar

• EMA’s CHMP Recommends Gene Therapy With Record Review Time (Focus)
• EMA Fees See 1.7% Increase (Focus)
• EU recommendations for 2019/2020 seasonal flu vaccine composition Share (EMA)
• Danish Agency Invites Pharma To Discuss EU Guide On Complex Trials (Pink Sheet-$)

• India's New Trial Rules Tick Right Boxes, Shed Interim Compensation Clause (Pink Sheet-$)
• Johnson & Johnson's baby shampoo samples fail Indian quality test; company rejects findings (Reuters)
• NPPA approves hike in prices of coronary stents (Economic Times)
• CDSCO rejects Cipla's application for marketing human insulin inhalation powder as SEC makes local trial compulsory (Pharmabiz)
• India needs a federal drug regulatory system for uniform implementation of drug laws and elimination of NSQ drugs from market: Study (Pharmabiz)

• Guidance for TGO 101: Standard for tablets, capsules and pills (TGA)
• Mylanta Antacid Double Strength Oral Liquid 500 mL (TGA)

• Alcohol, caffeine are common triggers of irregular heart rhythm (Reuters)
• Training A Computer To Read Mammograms As Well As A Doctor (NPR)