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

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

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

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

After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

Fierce Pharma

DECEMBER 13, 2023

That's because the original verdict questioned the FDA's decision-making authority, prompting amicus brief submissions from high-profile industry players. Wade, abortion access is back up for debate in the Supreme Court. | The Supreme Court's final decision could have consequences beyond abortion access.

Biopharma

Biopharma FDA

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

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

APRIL 23, 2024

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News. The novel immunotherapy works by sparking activity from three types of immune cells.

FDA

FDA Patients Biopharma Pharma

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 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

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

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

Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

MedCity News

APRIL 2, 2024

Ipsen is acquiring global rights to a Sutro Biopharma antibody drug conjugate for a target that is not yet hit by any FDA-approved drugs. Merck is among the companies pursuing this target, but Sutro claims its ADC could be first and best in this class.

Biopharma

Biopharma FDA Pharma

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

APRIL 15, 2024

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

Safety

Safety FDA Leads Biopharma

AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

MedCity News

APRIL 1, 2024

The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.

FDA

FDA Biopharma Pharma

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

MedCity News

APRIL 24, 2024

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The post FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer appeared first on MedCity News.

FDA

FDA Patients 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

Blockbuster BeiGene Cancer Drug Adds Another FDA Approval

MedCity News

MARCH 10, 2024

The FDA approved BeiGene’s Brukinsa as a treatment for advanced cases of follicular lymphoma. It’s the fifth FDA nod for the drug, which has become BeiGene’s top-selling product.

FDA

FDA Biopharma Pharma

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

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

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

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

MedCity News

APRIL 29, 2024

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The post Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency appeared first on MedCity News.

FDA

FDA Pharmaceutical Biopharma Pharma

Novartis Kidney Disease Drug Hits First Goal of Study; 2024 FDA Filing Planned

MedCity News

OCTOBER 2, 2023

Novartis’s iptacopan met the first of two main goals in its pivotal study in immunoglobulin A nephropathy, and the pharma giant plans to seek accelerated FDA approval next year. The drug could challenge two available therapies for the rare kidney disorder.

FDA

FDA Pharma Biopharma

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

MedCity News

APRIL 8, 2024

The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

FDA

FDA Patients Marketing Biopharma

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

Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug

MedCity News

MARCH 31, 2024

The FDA rejected the drug two years ago due to concerns about cardiovascular safety. Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020.

FDA

FDA Safety Marketing 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

Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

MedCity News

JANUARY 16, 2024

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease.

FDA

FDA Pharmaceutical Leads Biopharma

Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

MedCity News

MARCH 26, 2024

billion acquisition of Acceleron Pharma. Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5

FDA

FDA Pharma Biopharma

Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

MedCity News

FEBRUARY 23, 2023

FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster Roche drug Hemlibra.

Competition

Competition FDA Patients Pharma

Gene Therapy Is Now First FDA-Approved Treatment for Rare & Fatal CNS Disorder

MedCity News

MARCH 18, 2024

Orchard Therapeutics gene therapy Lenmeldy won FDA approval for treating the rare enzyme deficiency metachromatic leukodystrophy. In January, Kyowa Kirin completed its acquisition of Orchard, which now operates as a subsidiary of the Japanese drugmaker.

FDA

FDA Biopharma Pharma

Pharma M&A rumour mill grinds out Mirati’s name again

pharmaphorum

NOVEMBER 24, 2022

Mirati Therapeutics is the subject of takeover speculation in the biopharma sector once again, as it waits for the FDA’s decision on its KRAS inhibitor adagrasib in non-small cell lung cancer (NSCLC). The post Pharma M&A rumour mill grinds out Mirati’s name again appeared first on.

Pharma

Pharma Biopharma FDA Competition

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

MedCity News

MARCH 22, 2024

FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects.

Side effects

Side effects FDA Patients Biopharma

FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

MedCity News

DECEMBER 28, 2023

The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states.

FDA

FDA Management Biopharma Pharma

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

FDA

FDA Leads Pharmaceutical Patients

FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

MedCity News

FEBRUARY 14, 2024

Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment.

FDA

FDA Pharmaceutical Biopharma Pharma

FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

MedCity News

NOVEMBER 28, 2023

CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.

FDA

FDA Patients Biopharma Pharma

AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

MedCity News

MARCH 14, 2024

AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug.

Pharma

Pharma FDA Pharmaceutical Marketing

Chiesi expands rare disease portfolio with Amryt Pharma acquisition

pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. is to acquire the 2015-established Amryt Pharma Plc. The post Chiesi expands rare disease portfolio with Amryt Pharma acquisition appeared first on. in an all-cash transaction at $14.50 per American Depositary Share (ADS). Each ADS represents five Amryt ordinary shares.

Pharma

Pharma Biopharma Management Medicine

FDA Approves Iovance Cancer Treatment, the First Cell Therapy for a Solid Tumor

MedCity News

FEBRUARY 19, 2024

Iovance Biotherapeutics’s Amtagvi is now the first FDA-approved treatment based on type of cell called a tumor-infiltrating lymphocyte. The regulatory nod in advanced melanoma also makes Amtagvi the first cell therapy approved for treating a solid tumor.

FDA

FDA Biopharma Pharma

FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants

MedCity News

SEPTEMBER 11, 2023

The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.

FDA

FDA Biopharma Pharma

FDA finally signs off on Fennec Pharma drug for chemo-caused hearing loss in kids

MedCity News

SEPTEMBER 21, 2022

The regulatory decision comes more than two years later than expected, but the company now claims its drug, Pedmark, is the first and only FDA-approved therapy for reducing the risk of chemotherapy-induced hearing loss in pediatric cancer patients.

FDA

FDA Pharma Pharmaceutical Patients

Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

FDA

FDA Patients Safety Biopharma

Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing

MedCity News

OCTOBER 22, 2023

The FDA approved Pfizer’s Penbraya for vaccinating against five bacterial groups that can cause meningococcal disease. Pfizer already has vaccines covering those groups, but Penbraya addresses all of them in a single vaccine, making dosing easier for patients.

FDA

FDA Patients Biopharma Pharma

The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

MARCH 25, 2022

5 While the CDC gathers information on these topics for public health planning, there are immediate needs that pharma can address. . What Can Pharma Do? The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Findings note that caregivers are a vital source of information.

Pharma

Pharma Education Transportation Training

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

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

Trending Sources

Q1 Biopharma Recap

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

After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

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

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

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

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

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

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

Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

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

Blockbuster BeiGene Cancer Drug Adds Another FDA Approval

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

Ipsen beefs up in oncology, buying US biopharma Epizyme

FDA Rejects Eli Lilly Ulcerative Colitis Drug Over Manufacturing Issues

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

Novartis Kidney Disease Drug Hits First Goal of Study; 2024 FDA Filing Planned

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

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

Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug

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

Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

Gene Therapy Is Now First FDA-Approved Treatment for Rare & Fatal CNS Disorder

Pharma M&A rumour mill grinds out Mirati’s name again

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

Chiesi expands rare disease portfolio with Amryt Pharma acquisition

FDA Approves Iovance Cancer Treatment, the First Cell Therapy for a Solid Tumor

FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants

FDA finally signs off on Fennec Pharma drug for chemo-caused hearing loss in kids

Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing

The Caregiver Vertical: How Pharma Engages

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