Biopharma, FDA and Pharma - Pharma Rep Focus

Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

MedCity News

NOVEMBER 6, 2024

The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome. The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

FDA

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Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More

MedCity News

JANUARY 8, 2025

The post Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More appeared first on MedCity News. Metabolic medicines dominated life sciences headlines in 2024, a trend expected to continue into the new year.

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FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

MedCity News

NOVEMBER 25, 2024

BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis. But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March.

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Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels

MedCity News

MARCH 23, 2025

Novartiss Fabhalta is the first FDA-approved therapy for C3 glomerulopathy. But Apellis Pharmaceuticals Empaveli has superior clinical data, and that drug has been submitted for FDA review in the same rare kidney disease as well as another one that does not yet have an approved therapy.

FDA

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Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

MedCity News

JANUARY 31, 2025

Vertex Pharmaceuticals Jounavx is now FDA approved, providing patients a non-opioid option for treating acute pain. The post Vertex Pharmas Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds appeared first on MedCity News.

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‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

MedCity News

NOVEMBER 10, 2024

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

FDA

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FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

MedCity News

NOVEMBER 8, 2024

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

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PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain

MedCity News

NOVEMBER 14, 2024

FDA approval for the product comes two years after it won its first regulatory approvals in Europe. The post PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain appeared first on MedCity News.

FDA

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Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

MedCity News

NOVEMBER 22, 2024

A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases.

FDA

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Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions

MedCity News

APRIL 2, 2025

As the FDAs top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and mass layoffs throughout the FDA raise concerns about the agencys ability to review and potentially approve such treatments.

FDA

FDA Biopharma Pharma

Eli Lilly’s Zepbound Becomes First FDA-Approved Drug Therapy for Sleep Apnea

MedCity News

DECEMBER 22, 2024

The post Eli Lillys Zepbound Becomes First FDA-Approved Drug Therapy for Sleep Apnea appeared first on MedCity News. Zepbounds clinical tests in obstructive sleep apnea showed improvement in breathing disruptions that were accompanied by reductions in body weight.

FDA

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Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

MedCity News

DECEMBER 30, 2024

Axsome Therapeutics aims to offer an alternative to Rexulti, a Lundbeck and Otsuka Pharmaceutical product that is the only FDA-approved Alzheimers agitation drug. The post Axsome Aims for FDA Filing in Alzheimers Agitation Despite Mixed Bag of Phase 3 Data appeared first on MedCity News.

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Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings

MedCity News

NOVEMBER 1, 2024

The post Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings appeared first on MedCity News. Based on these preliminary results, the company plans to seek U.S. and European Union approvals in this indication in 2025.

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Bristol Myers Squibb Wins FDA Nod for Injectable Version of Blockbuster Cancer Drug

MedCity News

DECEMBER 30, 2024

Opdivo Qvantig, administered by injection in less than five minutes, is now FDA approved for solid tumor indications covered by Opdivo, a 30-minute intravenous infusion. The post Bristol Myers Squibb Wins FDA Nod for Injectable Version of Blockbuster Cancer Drug appeared first on MedCity News.

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Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder

MedCity News

DECEMBER 16, 2024

Neurocrine Biosciences Crenessity is now FDA approved for treating classic congenital adrenal hyperplasia (CAH), a rare and potentially fatal endocrine disorder. The post Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder appeared first on MedCity News.

FDA

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Rare Metabolic Disease That Leads to Childhood Obesity Gets Its First FDA-Approved Drug

MedCity News

MARCH 27, 2025

Soleno Therapeutics Vykat XR is now FDA approved for treating hyperphagia, or excessive hunger, in patients with Prader-Willi syndrome. The post Rare Metabolic Disease That Leads to Childhood Obesity Gets Its First FDA-Approved Drug appeared first on MedCity News.

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New FDA Approval Adds Chronic Kidney Disease to Ozempic’s Label

MedCity News

JANUARY 29, 2025

The new FDA approval comes as makers of GLP-1 drugs work to expand the uses of these products. The post New FDA Approval Adds Chronic Kidney Disease to Ozempics Label appeared first on MedCity News. Novo Nordisks type 2 diabetes drug Ozempic has expanded its label to include chronic kidney disease.

FDA

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Denali’s Data in Rare Enzyme Deficiency Keep It on Pace to Seek Speedy FDA Approval

MedCity News

FEBRUARY 6, 2025

Denali Therapeutics’ technology gets its drug across the protective membrane, and the biotech plans to seek accelerated FDA approval in this rare disease. The post Denalis Data in Rare Enzyme Deficiency Keep It on Pace to Seek Speedy FDA Approval appeared first on MedCity News.

FDA

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Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

MedCity News

AUGUST 12, 2024

FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. The post Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency appeared first on MedCity News.

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Novo Nordisk Commits $285M to Ascendis to Kick Off Alliance on Longer-Acting GLP-1 Drugs

MedCity News

NOVEMBER 4, 2024

This product candidate will be developed with Ascendis Pharma technology that has already yielded two FDA-approved products with longer dosing intervals. The Novo Nordisk/Ascendis partnership’s lead program is once-monthly injectable semaglutide for type 2 diabetes and obesity.

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FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection

MedCity News

MARCH 26, 2025

The FDA approved GSK antibiotic Blujepa as a treatment for uncomplicated urinary tract infections. The post FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection appeared first on MedCity News.

FDA

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Pfizer Ends Sangamo Alliance With Gene Therapy for Hemophilia on Cusp of FDA Filing

MedCity News

DECEMBER 31, 2024

The post Pfizer Ends Sangamo Alliance With Gene Therapy for Hemophilia on Cusp of FDA Filing appeared first on MedCity News. Pfizer is walking away from partner Sangamo Therapeutics ahead of expected regulatory submissions for the hemophilia A gene therapy they co-developed.

FDA

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FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

MedCity News

JULY 28, 2024

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. The post FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer appeared first on MedCity News.

FDA

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FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

FDA

FDA Biopharma

Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

MedCity News

JUNE 27, 2024

The post Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD appeared first on MedCity News. Verona executives contend their inhalable drug has key advantages over the last novel COPD medication, the orally administered roflumilast.

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FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

MedCity News

NOVEMBER 7, 2023

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

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Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

MedCity News

NOVEMBER 18, 2024

The post Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval appeared first on MedCity News. Other companies developing menin inhibitors include Kura Oncology, Biomea Fusion, and Johnson & Johnson subsidiary Janssen.

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Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer

MedCity News

OCTOBER 21, 2024

The FDA approved Astellas’s Vyloy as a treatment for advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for a protein called claudin 18.2. It’s the first FDA-approved therapy for this target.

Pharma

Pharma FDA Biopharma

Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Fierce Pharma

DECEMBER 27, 2023

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

FDA

FDA Biopharma

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

MedCity News

MARCH 14, 2024

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

FDA

FDA Pharma Pharmaceutical Biopharma

New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds

MedCity News

SEPTEMBER 16, 2024

Eli Lilly drug Ebglyss is now FDA-approved for atopic dermatitis, an inflammatory skin disorder also known as eczema. The post New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds appeared first on MedCity News. The biologic drug came from Lilly’s $1.1 billion acquisition of Dermira in 2020.

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Seeing a Better Way for Eye Drug R&D, Character Bio Lands $93M for Two Trials in Dry AMD

MedCity News

MARCH 25, 2025

Apellis Pharmaceuticals and Astellas Pharma have the first two FDA-approved therapies for geographic atrophy, but Character Biosciences claims its approach could be best in class for treating this advanced form of dry age-related macular degeneration.

Pharma

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SCOTUS overturn of Chevron doctrine opens a Pandora's box for biopharma industry, expert says

Fierce Pharma

AUGUST 27, 2024

. | In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services. An expert recently discussed the ramifications of the ruling during a Fierce Pharma podcast interview.

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Highly Anticipated FDA Decision Comes Just in Time for Back-to-School Season

MedCity News

SEPTEMBER 2, 2024

FDA approval of neffy, a nasal spray formulation of epinephrine, clears the way for ARS Pharma to launch the product in time for the new school year. In other recent regulatory news, the FDA approved updated Covid-19 vaccines as well as a new mpox vaccine.

FDA

FDA Pharma Biopharma

FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine

MedCity News

SEPTEMBER 20, 2023

Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission. ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen.

FDA

FDA Pharma Pharmaceutical Biopharma

FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

MedCity News

SEPTEMBER 27, 2024

The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics. The post FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades appeared first on MedCity News.

FDA

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FDA Approval of Drug for Rare Tumors Enables SpringWorks to Challenge AstraZeneca

MedCity News

FEBRUARY 12, 2025

SpringWorks Therapeutics Gomekli is now FDA approved for treating tumors caused by the rare genetic disorder neurofibromatosis type 1. The post FDA Approval of Drug for Rare Tumors Enables SpringWorks to Challenge AstraZeneca appeared first on MedCity News.

FDA

FDA Biopharma Pharma

FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

MedCity News

JUNE 21, 2024

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.

FDA

FDA Biopharma Pharma

Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

MedCity News

JULY 18, 2024

Expanded FDA approval of Phathom Pharmaceuticals drug Voquezna now includes patients with non-erosive gastroesophageal reflux disease (GERD). The post Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients appeared first on MedCity News. Phathom licensed its flagship product from Takeda Pharmaceutical.

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FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

MedCity News

AUGUST 7, 2022

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.

FDA

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Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

MedCity News

DECEMBER 19, 2023

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. billion Amryt Pharma acquisition. The birch tree bark-derived drug is from Chiesi’s $1.25

FDA

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FDA Rejects Eli Lilly Ulcerative Colitis Drug Over Manufacturing Issues

MedCity News

APRIL 13, 2023

Rejection of Eli Lilly’s mirikizumab means that two of the four drugs the pharma giant identified as revenue growth drivers for 2023 have failed to pass the regulatory bar. One of those drugs has been approved while the fourth drug still awaits an FDA decision.

FDA

FDA Manufacturing Pharma Biopharma

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

MedCity News

JANUARY 2, 2025

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions. The post FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions appeared first on MedCity News.

FDA

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RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

Fierce Pharma

DECEMBER 2, 2024

Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%. Kennedy Jr.’s s appointment last month to lead the U.S.

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Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More

Trending Sources

FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels

Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain

Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions

Eli Lilly’s Zepbound Becomes First FDA-Approved Drug Therapy for Sleep Apnea

Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings

Bristol Myers Squibb Wins FDA Nod for Injectable Version of Blockbuster Cancer Drug

Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder

Rare Metabolic Disease That Leads to Childhood Obesity Gets Its First FDA-Approved Drug

New FDA Approval Adds Chronic Kidney Disease to Ozempic’s Label

Denali’s Data in Rare Enzyme Deficiency Keep It on Pace to Seek Speedy FDA Approval

Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

Novo Nordisk Commits $285M to Ascendis to Kick Off Alliance on Longer-Acting GLP-1 Drugs

FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection

Pfizer Ends Sangamo Alliance With Gene Therapy for Hemophilia on Cusp of FDA Filing

FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer

Amgen's request for full approval of Lumakras in lung cancer denied by FDA

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds

Seeing a Better Way for Eye Drug R&D, Character Bio Lands $93M for Two Trials in Dry AMD

SCOTUS overturn of Chevron doctrine opens a Pandora's box for biopharma industry, expert says

Highly Anticipated FDA Decision Comes Just in Time for Back-to-School Season

FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine

FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

FDA Approval of Drug for Rare Tumors Enables SpringWorks to Challenge AstraZeneca

FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

FDA Rejects Eli Lilly Ulcerative Colitis Drug Over Manufacturing Issues

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

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