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Weekly News Recap #Phispers

FDA approves Emergent's smallpox vaccine for mpox; Lilly inks up to US$ 1 bn deal with Haya to target obesity

This week saw the US Food and Drug Administration (FDA) respond to the global monkeypox (mpox) public health emergency by expan...

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Lilly, Pfizer move to sell drugs directly to consumers; blast at Indian drug factory kills 17

An Indian factory that makes drugs for export to the US and other Western nations saw an explosion, caused by a chemical solven...

Impressions : 1313

IRA price talks conclude, three meds dominate savings; Gilead's Livdelzi from CymaBay buyout gets FDA okay

This week, the Biden-Harris Administration said it has concluded price negotiations for 10 drugs under the Inflation Reduction ...

Impressions : 525

FDA rejects first MDMA therapy to treat PTSD; Merck, Curon ink up to US$ 1.3 bn deal for next-gen bispecific antibody

The US Food and Drug Administration (FDA) has declined to approve an MDMA-assisted therapy from Lykos Therapeutics to treat pos...

Impressions : 1210

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FDA approves Emergent's smallpox vaccine for mpox; Lilly inks up to US$ 1 bn deal with Haya to target obesity

Lilly, Pfizer move to sell drugs directly to consumers; blast at Indian drug factory kills 17

IRA price talks conclude, three meds dominate savings; Gilead's Livdelzi from CymaBay buyout gets FDA okay

FDA rejects first MDMA therapy to treat PTSD; Merck, Curon ink up to US$ 1.3 bn deal for next-gen bispecific antibody

Roche's Piasky (Crovalimab) Receives Approval in Europe

Johnson & Johnson's Balversa (Erdafitinib) Receives Approval in Europe

Sanofi's Biologic Toujeo Max (Insulin Glargine) Receives Suppl Approvals in US

Zydus's Generics Scopolamine Receives Approval in US

Amphastar's Biologic Amphadase (Hyaluronidase) Receives Suppl Approvals in US

Qilu Pharmaceutical's Generics Sugammadex Receives Tentative Approval in US

Chartwell Pharma's Generics Glycopyrrolate Receives Approval in US

Hetero's Generics Dextromethorphan HBr, Quinidine Sulfate Receive Approval in US

Lupin's Generics Brimonidine Tartrate Receives Approval in US

Alvotech's Biologic Simlandi (Adalimumab) Receives Suppl Approvals in US

Enforcement Report - Week of September 4, 2024

Kaylaan LLC Receives FDA Warning Letter

FDA Issues Form 483 to Otsuka Pharmaceutical Co.

FDA Issues Form 483 to Global Calcium Private

Enforcement Report - Week of August 28, 2024

Berkeley Biologics Receives FDA Warning Letter

CARsgen Therapeutics Receives FDA Warning Letter

EyePoint Pharmaceuticals Receives FDA Warning Letter

Enforcement Report - Week of August 21, 2024

Boulla Issues Voluntary Nationwide Recall For Sildenafil

Lykos CEO to depart after FDA rejection, layoffs

Amgen Plans Phase III Program for Next-Gen Obesity Drug Targeting Liver and Kidney Diseases

Lilly Gains Ground on Novo With Positive Phase III Readouts for Weekly Insulin

A series of dice with a bag on them illustrating cost cuts ImmunityBio turns to layoffs after recent FDA nod for Anktiva

GSK's asthma drug Nucala meets main goal in study on treating smoker's lungs

Despite trial scare, Travere's IgAN drug wins full FDA approval

Innate Pharma Announces Call and Webcast for H1 2024 Financial Results

Medincell's Partner Teva Updates on Phase 3 of Olanzapine Long-Acting Injectable

LEO Pharma Shows Largest Data on Chronic Hand Eczema at ESCD 2024

Ora Partners with Institute of Eye Surgery to Enhance Ophthalmology Access

DEA Increases Production Limits on Takeda's Vyvanse Amid Ongoing Shortages

Apotex Launches First Generic Dasatinib Tablets in the United States

Zydus Gains Final FDA Approval for Amantadine ER Capsules and Tentative 137 mg

Biocon unit gets USFDA nod for generic drug

Zydus Lifesciences gets USFDA nod for generic medication

Lupin receives U.S. FDA approval for Brimonidine Tartrate Ophthalmic Solution

Fresenius Kabi Expands Women's Health Portfolio With Generic Option

Alembic Pharma gets USFDA nod for generic drug

Sunshine Biopharma Has Launched Nine New Generic Prescription Drugs in 2024

Biogen Sued Over Alleged PBM Kickbacks For Tecfidera

Despite trial scare, Travere's IgAN drug wins full FDA approval

A series of dice with a bag on them illustrating cost cuts ImmunityBio turns to layoffs after recent FDA nod for Anktiva

IN8bio Halts Ph 2 Glioblastoma Trial, Focuses on Leukemia Therapy After Layoffs

Moderna's Mpox Vaccine Shows Better Outcomes in Monkeys Than Bavarian Nordic

Poseida Therapeutics Presents Ph 1 Data on CAR-T P-BCMA-ALLO1 at Myeloma Meeting

Medera Inc. to List on NASDAQ via Merger with Keen Vision Acquisition Corp

Armata Pharmaceuticals Joins H.C. Wainwright Global Investment Conference

Cyclo Therapeutics Presents Phase 3 Safety Data for Niemann-Pick Disease C1

Sarepta Therapeutics Announces 2024-25 Route 79 Duchenne Scholarship Recipients

Novotech Releases 2024 Report on Pancreatic Cancer Trials and Drug Development

Olon to Boost API Production with HuvePharma Italia Acquisition

Fairfax, Bain look to buy Gujarat API company Farmson

Wanbury bags safety awards for its API manufacturing site in Patalganga

Mangalam Drugs expanding anti-malaria APl portfolio with Pyronaridine

Sequent receives WHO prequalification approval for Albendazole API

Wanbury appoints Prakash Venkatraman as President of API business

Asymchem Opens First European API Plant In UK

Aarti Drugs posts Q1 FY25 PAT lower at Rs. 33.3 Cr

Telangana DCA Seizes Illegal APIs Worth 1 Crore From Aspen Biopharma

BeiGene enhances biologic capability with new US facility

Lupin, Dr Reddy's recall products in US due to manufacturing issues

Dr. Reddy's banned from China's drug procurement program after inspectors

CDSCO reports low failure rate in cough syrup testing enhanced supply monitoring

CARsgen Warning Letter Notes Company Paused Manufacture Following 483

Zydus Lifesciences Gets Warning Letter From USFDA For Jarod Injectable Unit

Global Calcium Receives FDA Form 483 After Plant Inspection

EyePoint Receives FDA Warning Letter For Eye Implant Manufacturing Issues

Infant Formula Recall Update as FDA Issues Concern Level

Aurobindo, Glenmark, FDC Recall US Products Over Manufacturing Issues

U.S. FDA issues observations to Dr. Reddy's unit in Srikakulam

Aptar Digital Health Launches Asthma Study with Guy's and St Thomas' NHS

Florida State University Sets New Standard in Skin Cancer Detection

AscellaHealth Honored in SHSMD Calendar for Gene Therapy Awareness Month