Recon: FDA extends fridge storage for Pfizer vaccine; Catch up on news from ASCO

• Pfizer COVID-19 vaccine can be stored in refrigerator for a month, U.S. says (Reuters) (FDA)
• Fauci expects COVID-19 vaccines for kids in late-2021, sees need for booster shot (Reuters)
• New Bristol Myers immunotherapy combo better than Opdivo alone in melanoma study (Reuters) (STAT)
• Emergent may be able to resume J&J COVID-19 shot production 'within days' -CEO (Reuters)
• 100 Million Vaccine Doses Held Up Over Contamination Concerns, Firm Reveals (NYTimes)
• Be the spark? Roche’s Spark sues fellow gene therapy developer bluebird for ‘usurpation’ of trademark (Endpoints) (STAT)
• CVS Health offers clinical trial services (Reuters)

• China's current COVID-19 vaccines can tackle Indian variants - China CDC experts (Reuters)
• Current COVID vaccines appear protective against variants, WHO Europe says (Reuters)
• European Commission signs third contract with BioNTech-Pfizer for 1.8 bln vaccine doses (Reuters)
• UK launches extensive trial of third booster shots of Covid vaccines (FT)
• Hungary has opted out of new EU vaccine deal with Pfizer (Reuters)
• Roche aims Tecentriq at early lung cancer after data shows benefit (Reuters)
• Malawi burns nearly 20,000 expired COVID-19 shots despite assurances on shelf life (Reuters)
• S.Korea says to run mix-and-match trial of COVID-19 vaccines (Reuters)
• Swiss government stocks up Lonza workforce to help make Moderna vaccine (Reuters)
• French court orders damages for victims of PIP breast implant scandal (Reuters) (BBC)
• Big pharma and private equity seek healthy returns in Europe's east (Reuters)
• UN bodies set up 'One Health' panel to advise on animal disease risks (Reuters)

• 'Dramatic' COVID-19 improvement in U.S. but vaccine gaps elsewhere, PAHO says (Reuters)
• Pfizer, BioNTech to deliver 60 mln more COVID-19 vaccine doses to Turkey (Reuters)
• FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments (FDA)
• FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination (FDA)
• Republican lawmakers tell Biden to reverse ‘disastrous decision’ to support Covid-19 IP waiver (STAT)
• Minority patients underrepresented in Covid-19 trials despite greater willingness to participate, report finds (Endpoints)
• Japan Govt Eyes Expedited Approval Process to Push Homegrown Vaccines (PharmaJapan)

• Flurry of guidance documents, updated risk criteria for Covid-19 mAbs, personnel moves and more (Endpoints)
• Data Firms Form Real-World Evidence Alliance, Giving Them A Voice With US FDA, Congress (Pink Sheet)
• Hours after another FDA delay, Iovance CEO resigns — shares plummet (Endpoints) (STAT)
• FDA seeking more consistency from cell, gene therapy developers, top official says (BioPharmaDive)
• Voyager CEO Andre Turenne resigns amid setbacks, as the biotech pivots back to discovery (Endpoints)
• US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization (Pink Sheet)
• FDA adcomm to review FibroGen’s chronic kidney disease drug in July (Endpoints)
• #ASCO21: J&J busts out a small update for its antibody-TKI combo in lung cancer — whetting appetites as FDA thinks it over (Endpoints)
• With new data, J&J’s CAR-T drug benefits myeloma patients with less advanced disease (STAT)
• #ASCO21: Ahead of August PDUFA date, Astellas and Seagen sweeten Padcev pitch with new data (Endpoints)
• Merus drug shows potential as treatment for rare type of pancreatic cancer (STAT)
• #ASCO21: Allogene sets out to prove that their off-the-shelf approach to CAR-T can beat the personalized approach (Endpoints) (STAT)
• #ASCO21: AbbVie-partnered Chinese biotech with first-in-class ambitions showcases early data on CD73 antibody (Endpoints)
• Aiming to spur the immune responses that checkpoint inhibitors can't, Swiss biotech Numab earns fresh round of cash (Endpoints)
• ASCO: I-Mab's checkpoint inhibitor drug helper uliledlimab sees early promise in Tecentriq cancer combo test (Fierce)
• Eli Lilly wraps up fifth and final tirzepatide PhIII trial, claiming a win over Sanofi's Lantus. The FDA awaits (Endpoints)
• ASCO: Sanofi says early amcenestrant data could see it be 'endocrine backbone therapy' in breast cancer (Fierce)
• #ASCO21: Adaptimmune gives first glimpse at pivotal data for what they hope will be first approved TCR (Endpoints) (Fierce)
• ASCO: Exelixis releases more details on Cabometyx thyroid cancer data that wooed Ipsen (Fierce)
• #ASCO21: Takeda fleshes out case for oral EGFR drug with follow-up pivotal data in non-small cell lung cancer (Endpoints)
• #ASCO21: Merck tacks on armor in early-line cancer fight with 2 Keytruda wins setting the tone (Endpoints)
• #ASCO21: With Bristol Myers set for its own big LAG-3 update at ASCO, Merck touts early success for a potential competitor (Endpoints)
• #ASCO21: EQRx's cheaper EGFR drug busts Iressa in head-to-head test, and a US filing could be right down the road (Endpoints)
• Looking to reshape the metastatic cancer landscape, HiberCell fills the tank with a slate of mid-stage tests queued up (Endpoints)
• Passage Bio loses two execs in one week as CFO, CMO pack their bags amid 'changing needs' (Endpoints)
• Idera officially puts to rest its Phase III trial in advanced melanoma; BeiGene nabs priority review for sNDA (Endpoints)
• Again Please: BioMarin Seeks Speedy EU Review For Hemophilia Gene Therapy (Pink Sheet)
• FDA priority review granted for BeiGene’s Brukinsa for marginal zone lymphoma (PMLive)
• EMA, MHRA to review Vertex' Kaftrio for children with CF (PharmaTimes)
• NICE turns down Janssen's Erleada (PharmaTimes)
• NHS patients with rare blood disorders gain access to Ultomiris (PharmaTimes)
• Research Industry Presents United Front On Japan Reforms (Pink Sheet)

• Q1 Recalls Snapshot: It’s A Mixed Bag As Device Recalls Fall 10% But Recalled Units Rise 3% (MedtechInsight)
• ASCO: New data set up Veracyte’s nasal swab lung cancer test for launch later this year (Fierce)
• ‘It’s almost like placing an IV’: Brain monitoring electrode receives FDA 510(k) clearance (TC)

• Fewer state Medicaid programs are restricting access to hepatitis C medicines, but hurdles remain (STAT)
• California could become first state to mandate biosecurity screening by mail-order DNA companies (STAT)
• House passes drug bill that stalled over Jan. 6 tensions (The Hill)
• CARES Act Dooms Claim Targeting the Marketing of “Infant” Acetaminophen (Drug & Device Law)
• Bio-Rad Laboratories, Inc. v. Int'l. Trade Comm. (Fed. Cir. 2021) (Patent Docs)
• 5th Circ. Revives Conspiracy Case Against Quest Diagnostics (Law360)
• House Again Passes Bill To Reform Orphan Drug Exclusivity (Law360)
• Biogen Asks Justices To Review Pfizer's MS Drug Win (Law360)
• Akin Gump Beefs Up In DC With Addition Of Ex-FDA Official (Law360)
• Hikma Urges Justices To Skip Case On Obviousness Evidence (Law360)
• Sens. Pitch Bill To Regulate CBD Products In Food And Drink (Law360)
• FTC Wants Shkreli Sanctioned For Allegedly Wiping Phone (Law360)
• Supplement Retailers Plead Guilty in Cases Involving Distribution of Designer Steroids as Dietary Supplements (DOJ)