Recon: Novartis’ Zolgensma Study Halted on Safety Concerns; FDA Panel Backs Withdrawing Approval for Amag’s Makena

• Novartis' Zolgensma study halted by FDA amid safety questions (Reuters) (Endpoints) (STAT)
• FDA panel recommends removing the Makena drug for preventing premature births (STAT) (BioPharmaDive) (Endpoints) (Evaluate)
• Small relief for Biogen in MS drug approval (Reuters) (Endpoints) (Press)
• Amgen posts higher biosimilar sales, ends neuroscience program (Reuters) (Financial Times)
• After big gains, Cystic Fibrosis Foundation bankrolls research toward cures — and drugs for those left out (STAT) (Endpoints)
• Ex-FDA chief Gottlieb sees investment opportunity in 'unloved' antibiotics (Reuters) (Endpoints)
• Senate Democrats try to reverse Trump on Obamacare waivers (Politico)
• House Democrats clash over Pelosi's drug pricing bill (The Hill)

• US, EU regulators start review of Roche’s Soliris rival satralizumab (PMLive) (Press)
• IOM suspends some Ebola screening after three aid workers killed in South Sudan (Reuters)
• AstraZeneca sells European rights for schizophrenia drug to Cheplapharm (Reuters)
• US sanctions on Iran threaten access to certain medicines: report (Reuters)
• In a bid to get to Chinese patients faster, Shanghai's I-Mab plans $100M Nasdaq IPO (Endpoints)
• Bayer: Encouraging business performance across all divisions – agreements signed to divest Currenta and Animal Health (Press)
• UK's Johnson, Corbyn bicker over US trade and Vertex deal (Endpoints)
• Rich countries must pay more to achieve health for all in poorer countries (Financial Times)
• The fireman of global health: The WHO’s emergencies chief is put to the test (STAT)

• The ‘cancer growing in cancer medicine’: pharma money paid to doctors (STAT)
• GlaxoSmithKline's RIPK1 inhibitor dead on arrival (Fierce) (Endpoints)
• Merck CFO: we’re not only about Keytruda (PMLive)
• In generic drug plants in China and India, data falsification is still a problem (STAT)
• Merck siphons off Gardasil CDC supplies again as global sales surge (Fierce)
• ‘Gene-ie in a bottle’ gene therapy opportunity is a treasure trove but CMOs lack capacity (Pharmaceutical Technology)
• Catalyst Pharma's Firdapse bet on congenital myasthenic syndromes turns sour (Endpoints)
• Peter Hecht’s Ironwood spinout fails back-to-back studies on a key drug, crushing shares and triggering cutbacks — but he still sees a path forward (Endpoints)
• After Ignoring Letters From US FDA, Teva And Cipla Will Have ANDAs Withdrawn (Pink Sheet-$)
• A Trial For Kids At Risk Of Type 1 Diabetes Was Scaled Back, Leaving Families In Limbo (NPR)
• Why Antibiotics May Do More Harm Than Good For People With Bacteriuria (Forbes)
• Sanifit touts positive PhIIb data; REGENXBIO licenses Clearside Biomedical tech (Endpoints)
• Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)
• Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA) (FDA)

• Sanifit's calcification drug hits goal in renal disease phase 2b (Fierce)
• AstraZeneca to Present Pivotal Roxadustat Phase III Data at the American Society of Nephrology Kidney Week 2019 (Press)
• Alpine Immune Sciences Completes Enrollment of Phase I Study of ALPN-101 and Announces Third Quarter Conference Call (Press)
• Dendreon Completes Enrollment of Phase 3 ProVent Clinical Trial Evaluating Sipuleucel-T in Men on Active Surveillance (Press)

• Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples (FDA)
• Stryker beats street on Q3 earnings, shares drop after hours (MassDevice)
• General Electric jumps on Street-beating Q3 results, raised earnings outlook (MassDevice)
• LivaNova slumps on Q3 revenues miss (MassDevice)
• FDA Approval of Myriad Genetics CDx Adds HRD to Growing List of Ovarian Cancer Predictive Markers (GenomeWeb)
• Oxalert EPO™ Wearable Device Granted FDA Breakthrough Status (Press)
• Impulse Dynamics Announces US FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System (Press)

• Confidentiality Orders and Public Interest in Drug and Medical Device Litigation (JAMA)
• Another Chinese threat to our national security: Prescription drugs (The Hill)
• Juul Knowingly Sold Tainted Nicotine Pods, Former Executive Says (NYTimes)
• Mallinckrodt Defends Price Hike As Necessary To Save Drug (Law360-$)
• Grunenthal Earns PTAB Win In Challenge To Pain Treatment IP (Law360-$)
• Bayer risks mount as US pesticide lawsuits more than double (Financial Times)
• J&J's own expert, working for FDA, found asbestos in Baby Powder (Reuters)
• J&J says new tests find no asbestos in same baby powder bottle that sparked recall (Reuters)
• Primary Jurisdiction Forecloses Lanham Act Challenging Medical Device Classification (Drug & Device Law)
• FTC Sues Publisher for Targeting Seniors With Phony Diabetes Cure and Money Making Schemes (FTC)

• FDA Advisory Committee Calendar

• Class 2 Medicines Recall: Nutriflex Omega Plus 1250ml, 1875ml and 2500ml, PL 03551/0119, and Nutriflex Omega Special 625ml, 1250ml, 1875ml and 2500ml, PL 03551/0118 and Supplemented Product codes ASNSPOMCA, ASNSPOMSVA, ASNPLOMCA, ASNPLOMSVA (625ml, 1250ml, 1875ml 2500ml) (EL(19)A/31) (MHRA)

• Pakistan Steps Up Pharmacovigilance (Pink Sheet-$)
• An H.I.V. Outbreak Puts Spotlight on Pakistan’s Health Care System (NYTimes)
• Field report: Malaysian MDA medical device regulatory changes underway (Emergo)

• TGA presentation: Cybersecurity for medical devices (TGA)

• Breast cancer takes heavier financial toll on black and rural women (Reuters)