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Weekly News Recap #Phispers

BMS med wins landmark FDA nod for schizophrenia; Sanofi's Dupixent approved to treat COPD

In this week’s Phispers, the US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s groundbreaking s...

Impressions : 542

Sanofi gets two bids valuing its consumer unit at US$ 17 bn; Pfizer pulls SCD drug from market

In news this week, Sanofi is considering the sale of its consumer health unit and has received binding bids valuing the divisi...

Impressions : 964

FDA panel votes against Intercept's liver med Ocaliva; Lilly's Ebglyss wins approval for eczema

Intercept Pharmaceuticals faced a major setback as a US Food and Drug Administration (FDA) panel voted against the confirmato...

Impressions : 869

GSK's COPD, long-acting asthma drugs score late-stage wins; Novo's weight-loss drug Saxenda found to be safe in kids

GSK scored a significant late-stage win with its asthma drug Nucala in treating chronic obstructive pulmonary disease (COPD). I...

Impressions : 539

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BMS med wins landmark FDA nod for schizophrenia; Sanofi's Dupixent approved to treat COPD

Sanofi gets two bids valuing its consumer unit at US$ 17 bn; Pfizer pulls SCD drug from market

FDA panel votes against Intercept's liver med Ocaliva; Lilly's Ebglyss wins approval for eczema

GSK's COPD, long-acting asthma drugs score late-stage wins; Novo's weight-loss drug Saxenda found to be safe in kids

Zydus Pharma's Generics Paliperidone Receives Approval in US

Saptalis's Generics Glycopyrrolate Receives Approval in US

Novartis's Biologic Cosentyx (Secukinumab) Receives Approval in US

Hetero Lab's Generics Milnacipran HCl Receives Approval in US

Gland Pharma's Generics Chlorothiazide Na Receives Approval in US

Indoco's Generics Cetirizine HCl Receives Approval in US

Bristol Myers's Biologic Opdivo (Nivolumab) Receives Suppl Approval in US

Jubilant's Generics Solifenacin Receives Tentative Approval in US

Alembic's Generics Alcaftadine Receives Approval in US

MSN's Generics Nilotinib Receives Tentative Approval in US

Enforcement Report - Week of October 9, 2024

FDA Issues Form 483 to Aqualex Co., Ltd.

FDA Issues Form 483 to Nanchang Anobri Pharmaceutical Co.

FDA Issues Form 483 to Biocon Sdn.

FDA Issues Form 483 to Apitoria Pharma Private Ltd.

Enforcement Report - Week of October 2, 2024

MMC Healthcare Ltd. Receives FDA Warning Letter

Diamond Chemical Co. Receives FDA Warning Letter

Originitalia is on FDA Import Alert List

Aerosol and Liquid Packaging Receives FDA Warning Letter

EUROAPI completes financing of FOCUS-27 plan and moves forward

Eli Lilly inks another obesity pact, down on small Swiss partner

Denali-Sanofi scraps mid-stage study for multiple sclerosis drug

Zydus gets US nod for schizophrenia generic medicine

Gritstone files for bankruptcy in hope of keeping R&D afloat

Ono inks $700M biobuck deal to bag preclinical LigaChem ADC

Pfizer targets broad Talzenna label in prostate cancer

Roche burnishes breast cancer portfolio with FDA nod for Itovebi

More than 15 million US adults have ADHD, new study estimates

Sanofi in talks to sell 50% stake in consumer health business to CD&R

Zydus gets US nod for schizophrenia generic medicine

Curia Commits to SBTi Net-Zero Standard

Natco shares rise 4% order in US patent case over generic Ozempic

Novo settles with Mylan over potential Ozempic generic

Indoco receives U.S. FDA approval for generic Cetirizine tablets

Alembic gains FDA approval for Lamotrigine Extended-Release Tablets

Emcure Pharma partners with Gilead Sciences to produce HIV drug

Alembic Gains USFDA Approval For Lamotrigine Extended-Release

Access To HIV Drug Hinges On Waiver Of Local Clinical Trials

Dr Reddy's sign voluntary licenses with Gilead for HIV drug

Ono inks $700M biobuck deal to bag preclinical LigaChem ADC

Cantargia'sPh 2 Nadunolimab Data Published In Cancer Research

BenevolentAI To Present At BioTechX Europe 2024

Valneva Hosts Investor Day in New York City

Pharming Group Announces Starts Ph2 Trial Of Leniolisib For PIDs

Biogen reports promising results for higher dose of Spinraza

Schrödinger to Present Preclinical Data at 2024 EORTC Symposium

Merck To Present Vaccine And Infectious Disease Data At IDWeek

Vizgen And Ultivue Merge For Spatial Multi-Omics Innovation

Alnylam Submits sNDA to FDA For Vutrisiran In ATTR-CM

Moehs & EUROAPI Sign Agreement For Production Of Metamizole In EU

Ind-Ra forecasts weak API prices and volume growth for India

Ofichem will support IPCEI Med4Cure project as associated partner

Gilead Taps Yuhan To Supply HIV Drug Ingredients In $81M Deal

Snapdragon Develops New Liquid-Phase Peptide Synthesis Technology

Fermenta Biotech's Dahej facility gains EU GMP certification

Zydus Lifesciences Acquires API Business Of Sterling Biotech For Rs 84 Crore

Laurus Labs API Facility Passes USFDA Audit With Zero Observations

C2 Pharma Expands Ophthalmic API Portfolio

Wanbury announces new API product portfolio and launch plans

Alembic rises after oncology completes FDA with 'zero' observations

Medtronic recalls MiniMed insulin pumps over drained batteries

Medtronic Recalls MiniMed Pumps Due To Battery Life Risk

Lupin's Pune-based biotech facility gets 5 observations from US FDA

Govt may mandate QR codes to check fake cancer drugs

FDA boosts Philips recall of hospital, home ventilator software

Kezar Reports Four Patient Deaths in Mid-Stage Lupus Nephritis Study

USFDA Inspection Update On Jubilant HollisterStier's Facility

U.S. FDA issues 10 observations to Aurobindo arm's API unit

USFDA Completes Inspection At Biocon Biologics' Insulin Facility

More than 15 million US adults have ADHD, new study estimates

Manzil And Spectator Launch Tech-Enabled Home Care Partnership

Zcube Announces 5 Startups For New Edition Focused Women's Health