Biopharma, FDA and Pharma - Pharma Rep Focus

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

After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

Fierce Pharma

NOVEMBER 22, 2024

For many biopharmas, it takes years of hard work to transition from being a clinical-stage drugmaker to a commercial one. The pivot comes after the FDA issued a notice that the deficiencies in the company's approval bid for type 1 diabetes med Zynquista are too great to proceed for further discussion.

FDA

FDA Biopharma

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.

Biopharma

Biopharma FDA Pharma Healthcare

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

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

FDA Pharma Pharmaceutical Biopharma

Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Fierce Pharma

NOVEMBER 18, 2024

may not rock the boat as much as feared for the biopharma industry. Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr.

Biopharma

Biopharma FDA Marketing

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.

Biopharma

Biopharma FDA Leads

Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

AUGUST 20, 2024

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. |

Biopharma

Biopharma FDA

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.

FDA

FDA Pharma Competition Pharmaceutical

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.

Competition

Competition FDA Pharma Pharmaceutical

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.

Pharma

Pharma FDA Pharmaceutical 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.

Pharma

Pharma FDA Medical Patients

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

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.

Competition

Competition Pharma FDA Biopharma

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.

Biopharma

Biopharma Competition FDA Pharma

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

Q1 Biopharma Recap

Zymewire

APRIL 22, 2024

Summary of funding events, FDA approvals, clinical trial stats, and upcoming research and development plans from the world of biotech and pharma in Q1 2024

Biopharma

Biopharma FDA Pharma

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 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

FDA Safety Pharma Biopharma

Applied Therapeutics Drug Is Denied FDA Approval in Rare Inherited Metabolic Disease

MedCity News

DECEMBER 2, 2024

The FDA cited deficiencies in its govorestat’s application in galactosemia, a rare metabolic disease, Applied Therapeutics said. The biotech is still on track to submit a separate application for the drug in sorbitol dehydrogenase (SORD) deficiency, another rare disease that has no FDA-approved therapies.

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.

Pharma

Pharma Patients FDA Pharmaceutical

Pharma Pulse 9/5/24: FDA Wants Safer Cancer Drugs, Can Outcomes-Based Agreements Work for Weight Loss Drugs? & more

Pharmaceutical Commerce

SEPTEMBER 5, 2024

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

Distribution

Distribution Biopharma Pharma Marketing

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

FDA Patients Biopharma Pharma

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.

FDA

FDA Marketing Medicine Biopharma

‘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

FDA Engineering Safety Biopharma

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

FDA Biopharma Pharma

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

MedCity News

OCTOBER 16, 2024

The FDA approved Novocure medical device Optune Luna as a treatment for advanced cases of non-small cell lung cancer. The post Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer appeared first on MedCity News. The wearable technology delivers electrical fields that kill cancer cells.

Medical

Medical 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

Pharma Pulse 5/17/24: Apple Watch's Afib App certified by FDA, Learning Telehealth Platforms Benefits Pharmacy Students & more

Pharmaceutical Commerce

MAY 17, 2024

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

Distribution

Distribution Biopharma Pharma Marketing

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

Ipsen beefs up in oncology, buying US biopharma Epizyme

pharmaphorum

JUNE 27, 2022

The bolt-on deal comes shortly after Ipsen announced plans to sell its consumer health business for around €350 million, leaving it as a pure-play prescription pharma operating in the cancer, rare diseases and neuroscience categories. The post Ipsen beefs up in oncology, buying US biopharma Epizyme appeared first on.

Biopharma

Biopharma Sales Prescription FDA

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

FDA Pharma Biopharma

FDA Approves First-Of-Its Kind Drug to Ease Menopause Symptoms

MedCity News

MAY 14, 2023

Astellas Pharma won FDA approval for Veozah, a new menopause drug. The once-daily pill offers a new non-hormonal treatment option for addressing menopausal symptoms.

FDA

FDA Pharma Biopharma

A Non-Profit Pharma Nabs FDA Nod for Non-Prescription Naloxone Nasal Spray

MedCity News

JULY 30, 2023

The FDA approved RiVive, an over-the-counter version of naloxone nasal spray from Harm Reduction Therapeutics. It’s the second such approval from the FDA this year, following an affirmative decision in March for OTC Narcan.

FDA

FDA Prescription Pharma Biopharma

Enabling Clinical Trial Innovation Through AI Regulation at FDA

MedCity News

JULY 29, 2024

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

FDA

FDA Safety Healthcare Healthcare

Takeda Drug Wins First FDA Approval in Rare, Inherited Blood Clotting Disorder

MedCity News

NOVEMBER 12, 2023

Takeda Pharmaceutical enzyme replacement drug Adzynma is the first FDA-approved therapy for a rare blood disorder affecting fewer than 1,000 Americans. Our regulatory recap also includes the much-anticipated approval of an Eli Lilly weight loss drug and a crackdown on what the FTC says are improperly listed pharma product patents.

FDA

FDA Pharma Pharmaceutical Biopharma

FDA Approval Makes a Zevra Drug the First Therapy for Rare and Fatal Metabolic Disease

MedCity News

SEPTEMBER 20, 2024

Zevra Therapeutics drug Miplyffa is now FDA approved for Niemann-Pick disease type C, a lysosomal storage disorder. The affirmative regulatory decision took into account additional clinical data generated since the FDA turned down a submission for the drug in 2021.

FDA

FDA Biopharma Pharma

Pfizer Growth Hormone Drug Measures Up at FDA With O.K. for Weekly Dosing

MedCity News

JUNE 28, 2023

Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.

FDA

FDA Pharma Biopharma

Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD

MedCity News

SEPTEMBER 29, 2024

It’s the sixth FDA-approved indication for the blockbuster drug. The post Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD appeared first on MedCity News.

FDA

FDA Pharmaceutical Biopharma Pharma

Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

MedCity News

SEPTEMBER 6, 2024

The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News.

Competition

Competition FDA Patients Biopharma

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 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

FDA Pharma Pharmaceutical Patients

FDA Nod Makes Ferring Pharma Gene Therapy the First for Bladder Cancer

MedCity News

DECEMBER 19, 2022

A Ferring Pharmaceuticals gene therapy is now FDA approved for treating bladder cancer that does not respond to an immunotherapy used to treat the cancer in its early stages. The Ferring gene therapy, Adstiladrin, turns bladder wall cells into tiny factories churning out a cancer-fighting therapeutic protein.

FDA

FDA Pharma Pharmaceutical Biopharma

With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA

MedCity News

JULY 9, 2024

An accelerated approval pathway is one of the topics the company wants to discuss with the FDA. The post With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA appeared first on MedCity News.

FDA

FDA Biopharma Pharma

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

After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

Trending Sources

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

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

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

Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

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

Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

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

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

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

Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

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

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

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

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

Q1 Biopharma Recap

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

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

Applied Therapeutics Drug Is Denied FDA Approval in Rare Inherited Metabolic Disease

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

Pharma Pulse 9/5/24: FDA Wants Safer Cancer Drugs, Can Outcomes-Based Agreements Work for Weight Loss Drugs? & more

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

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

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

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

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

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

Pharma Pulse 5/17/24: Apple Watch's Afib App certified by FDA, Learning Telehealth Platforms Benefits Pharmacy Students & more

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

Ipsen beefs up in oncology, buying US biopharma Epizyme

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

FDA Approves First-Of-Its Kind Drug to Ease Menopause Symptoms

A Non-Profit Pharma Nabs FDA Nod for Non-Prescription Naloxone Nasal Spray

Enabling Clinical Trial Innovation Through AI Regulation at FDA

Takeda Drug Wins First FDA Approval in Rare, Inherited Blood Clotting Disorder

FDA Approval Makes a Zevra Drug the First Therapy for Rare and Fatal Metabolic Disease

Pfizer Growth Hormone Drug Measures Up at FDA With O.K. for Weekly Dosing

Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD

Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

FDA Rejects Eli Lilly Ulcerative Colitis Drug Over Manufacturing Issues

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

FDA Nod Makes Ferring Pharma Gene Therapy the First for Bladder Cancer

With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA

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