Recon: Lundbeck Buys Alder for $2B; Purdue Pharma Files for Bankruptcy

• First peanut allergy treatment gains backing from FDA advisory panel (Science) (Atlantic) (AP)
• Purdue Pharma, maker of OxyContin and other drugs, files for bankruptcy (Stat) (Bloomberg) (WSJ) (Guardian)
• Opioid Defendants Seek to Disqualify Judge Overseeing 2,300 Cases (NY Times)
• The Startup That Manipulated Data to Get a Miracle Drug to Market (WSJ)
• Biden Praises Pharma to Donors as He Pushes to Cut Prices (Bloomberg)
• EMA, FDA Begin Reviewing Heartburn Medicines for Carcinogen (Focus)
• Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation (Focus)

• Lundbeck buys Alder for $2 billion, eyes 'blockbuster' migraine therapy (Reuters) (Evaluate) (PMLive)
• ‘The switch’ was supposed to be a major step toward eradicating polio. Now it’s a quandary (Stat)
• Workshop on the use of registries for tumour histology-independent cancer therapies (EMA)
• U.S. Drugmakers Face New Intellectual Property Hurdles in China (Bloomberg Law-$)
• Biogen completes Spinraza registration for Russian market (PharmaLetter-$) (SMA News Today)
• Tanzania's Zanzibar begins to register traditional healers (Reuters)
• ICH E17 Guideline training materials available now (ICH)

• Amgen's Kyprolis, J&J's Darzalex team up on myeloma survival win (Fierce)
• Could editing the DNA of embryos with CRISPR help save people who are already alive? (Stat)
• Early Company Evolution – People, Pipeline, and Purse (Life Sci VC)
• After a run of CTLA-4 combo failures, scientists spotlight a way to make it work — in select patients (Endpoints)
• J&J taps AlivaMab for multi-target antibody discovery effort (Fierce)
• Purveyors Of Black-Market Pharmaceuticals Target Immigrants (Kaiser Health News)
• Gilead's Truvada keeps up PrEP TV push, lands at No. 2 in Aug. ad spending (Fierce)
• A Daily Baby Aspirin Could Help Many Pregnancies And Save Lives (NPR)
• In First, California Would Require Public Universities to Provide Abortion Pills (NY Times)
• Stakeholders To Gather In D.C. To Discuss U.S. Biosimilar Market's Future (Biosimilar Development)
• Deborah Dunsire is paying $2B for a chance to leap directly into a blockbuster showdown with a few of the world's biggest pharma giants (Endpoints)
• Rgenix Names Industry Veteran to Chief Medical Officer Role (Fierce) (Press Release)

• AGC Biologics to exit Berkeley CA plant by end of year (BioProcess International)
• GE Healthcare and Germfree to Advance Manufacturing of Novel Biotherapeutics (Contract Pharma)
• AstraZeneca diabetes drug granted fast track status for heart failure treatment (Reuters) (Press Release)
• Celgene's AML drug clears late-stage test (Endpoints)
• Novartis’ MS drug trumps Sanofi’s Aubagio (PharmaTimes)
• Atara's off-the-shelf T cells for EBV-driven MS show promise in small study (Fierce)
• FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug (Focus)
• Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer (Press Release)
• Precision BioSciences Announces FDA Clearance of the IND for PBCAR20A, a CD20 Targeting Genome Edited Allogeneic CAR T Therapy (Press Release)
• Tiziana Life Sciences Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers (Press Release)

• Medtronic, Novo Nordisk enter digital diabetes solutions deal (PharmaTimes)
• Pear Therapeutics CEO explains app for addiction treatment (AP)
• CRISPR-Chip Launched as “Genome Sensor” (GEN)
• Implant-Associated Cancers: A Look Beyond BIA-ALCL (Cancer Therapy Advisor)
• Cos. Reach $9.5M Deal For Selling Non-FDA Cleared Devices (Law360-$)
• Roche receives FDA clearance for cobas pro integrated solutions designed to help labs deliver faster results to patients (Press Release)

• Hybrid Pharma Form 483 (FDA)
• Former FDA chief Scott Gottlieb joins FasterCures Advisory Board (Press Release)
• Probabilistic Genotyping Software (GAO)
• Alliance for a Stronger FDA (Update)

• FDA Advisory Committee Calendar
• Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing (FDA)
• September 18, 2019: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement (FDA)
• Global Summit on Regulatory Science (GSRS) – 2019 (FDA)
• Implementing FDA’s Predictive Toxicology Roadmap: An Update of FDA Activities (FDA)

• How Europe can better tackle rising cancer incidence (Euractiv)
• CHMP agenda for the meeting on 16-19 September 2019 (EMA)
• 93 European Associations call for an Ambitious Horizon Europe Programme (EFPIA)
• Webinar (2) - Thematic Network EKHA - Improving Organ Donation and Transplantation in the EU (Broadcast)
• 5 policy suggestions for the ‘European way of life’ commissioner (Politico)

• Japan culls 753 hogs to contain swine fever outbreak (Reuters)