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May 29, 2020
by Michael Mezher

Recon: WHO launches COVID-19 IP pool with 30 countries; Sanofi vaccine chief heads to Ipsen

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Administration initially dispensed scarce covid-19 drug to some hospitals that didn’t need it (Washington Post)
  • Additional blood cancer responses seen with Allogene’s off-the-shelf CAR-T cells, updated study shows (STAT) (Endpoints)
  • US hospitals slash use of drug championed by Trump as coronavirus treatment (Reuters)
  • US FDA approves Eli Lilly's diagnostic agent for Alzheimer's disease (Reuters) (FDA) (Press)
  • Minerva's schizophrenia drug misses main goal in study; shares tumble (Reuters)
  • Watchdog groups want Trump's coronavirus vaccine czar to disclose all pharma ties (The Hill)
  • US senators offer bill to prepare for the next pandemic (Reuters)
In Focus: International
  • Thirty countries launch alliance to share COVID-19 tools (Reuters)
  • Pharma leaders shoot down WHO voluntary pool for patent rights on Covid-19 products (STAT) (PMLive)
  • EU launches new COVID-19 fundraising to address concerns over equal access (Reuters)
  • Sanofi's head of vaccines leaves for smaller competitor Ipsen (Reuters) (Endpoints 1, 2)
  • Pakistan drug firm to import potential COVID-19 treatment from Bangladesh (Reuters)
  • Sun Pharma to test pancreatitis drug in COVID-19 patients in India (Reuters)
  • South Korea seeks to import anti-viral remdesivir as new coronavirus cases emerge (Reuters)
  • AstraZeneca's top-selling drug slows early-stage lung cancer - trial (Reuters) (STAT) (Endpoints)
  • Takeda gets EU green light to keep bowel drug after Shire buy (Reuters) (Fierce) (Endpoints) (Press)
  • Germany pauses anti-malaria drug study for COVID-19: Spiegel (Reuters)
  • Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 (EMA)
Coronavirus Pandemic
  • Scientists Question Validity of Major Hydroxychloroquine Study (NYTimes)
  • COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (EMA)
  • Rising ICU bed use 'a big red flag' (Politico)
  • FDA authorizes Quest’s coronavirus test with at-home sample collection; shares rise (CNBC)
  • C.D.C. Recommends Sweeping Changes to American Offices (NYTimes)
  • Cancer, coronavirus are a dangerous mix, new studies find (NBC)
  • Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020 (FDA)
  • Facing vial shortage, pharmas explore workarounds for coronavirus vaccines (BioPharmaDive)
Pharma & Biotech
  • Bacteria are widespread in tumors, forming distinct populations depending on the cancer type (STAT)
  • AstraZeneca’s $7B ADC succeeds where Roche failed, improving survival in gastric cancer (Endpoints)
  • US FDA Office Of New Drugs Has New Deputy Director In Thanh Hai (Pink Sheet)
  • A Senator From Arizona Emerges As A Pharma Favorite (KHN)
  • Ironwood, AbbVie kick delayed-release Linzess formulation to the curb after trial failure (Endpoints)
  • After starring at ASH last fall, Gilead’s new Forty Seven crew colors in more promising data for magrolimab at ASCO (Endpoints)
  • ASCO: Pfizer, Merck KGaA's Bavencio posts win in rare gynecological cancer (Fierce) (Endpoints)
  • ASCO: Merck's Keytruda doubles time to disease progression in certain colorectal cancer patients (Fierce)
  • As tislelizumab gains traction in China, BeiGene pulls the curtain on NSCLC data supporting the PD-1 drug (Endpoints)
  • Early survival data boost Ziopharm's 'controlled IL-12' immunotherapy for glioblastoma (Endpoints)
  • Designer antibodies fight cancer by tethering immune cells to tumor cells (Science)
  • Kura flashes positive HRAS data on once-failed J&J drug (Endpoints)
  • Sierra Oncology brings on former Aimmune CEO to the helm; Flagship woos ex-Novartis exec Fabrice Chouraqui (Endpoints)
  • For Opioid Users, Pandemic Means New Dangers, But Also New Treatment Options (NPR)
  • FDA Accepts Fresenius Kabi Pegfilgrastim Biosimilar Candidate for Review (Big Molecule Watch)
  • Roche Seeks Speedy EMA Review For SMA Drug Risdiplam (Pink Sheet)
  • CVS, Nuro to test driverless prescription delivery in Houston area (Reuters)
  • Amgen Presents New AMG 510 Clinical Data Across Multiple Solid Tumors During ASCO20 Virtual Scientific Program (Press)
  • Takeda to Present Data from the ICLUSIG® (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML (Press)
  • Takeda Announces Compelling Data from the Phase 2 Trial of Pevonedistat Plus Azacitidine in Patients with Higher-Risk MDS (Press)
  • Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery (Press)
  • Libtayo® (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time (Press)
  • Updated data demonstrate Roche’s Alecensa increases overall survival rate for people with ALK-positive non-small cell lung cancer (Press)
Medtech
  • Four deaths trigger Class I recall for Medtronic's HeartWare implant (MedtechDive) (FDA)
  • How tariffs ravaged the COVID-19 medical supply chain (Supply Chain Dive)
Government & Regulatory
  • FDA Asks Full DC Circ. To Undo Eagle's Orphan Drug Win (Law360)
  • Pandemic upends state plans to expand health insurance (Politico)
  • Drug and medical device highlights 2019: Helping you maintain and improve your health (Health Canada)
  • Notice advising of NCEs to be included in the June 2020 Poisons Standard, May 2020 (TGA)
  • TGA stakeholder survey 2019 (TGA)
  • TGA initiates court proceedings against MMS Australia and director Charles Barton for alleged unlawful advertising (TGA)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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