Biopharma, FDA, Patients and 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.

FDA

FDA Patients Biopharma Pharma

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

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

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

FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

MedCity News

MAY 11, 2023

Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients. The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication.

FDA

FDA Patients Pharmaceutical Biopharma

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

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 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 regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.

FDA

FDA Patients Biopharma Pharma

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 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

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). Response rates above 50% in PD-1 high/intermediate patients with no liver tox surprises could set up for a potential acquisition.”

Pharma

Pharma Biopharma FDA Competition

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

MedCity News

AUGUST 5, 2022

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.

FDA

FDA Patients 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

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. He continued: “Amryt has steadily brought innovative products to new markets and, by adding them to the Chiesi portfolio, we hope to make them available to even more patients who may require them.”. on 6 th January.

Pharma

Pharma Biopharma Management Medicine

J&J multiple myeloma drug gets FDA nod, bringing patients an easier dosing option

MedCity News

OCTOBER 26, 2022

FDA approval of Tecvayli, from Johnson & Johnson subsidiary Janssen Biotech, makes it the newest therapy that treats multiple myeloma by targeting the cancer protein BCMA.

FDA

FDA Patients 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

Reducing real world data lag time for improved patient outcomes

Clarivate

MARCH 8, 2023

In recent years, there has been an increased focus on real world evidence to advance medical science and improve patient quality of life. Biopharma companies are investing in the use of real world data (RWD) to accelerate innovation. The treatment of patients experiencing acute disease is quite dynamic.

Patients

Patients Biopharma Medical science Electronics

The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

MARCH 25, 2022

Although the caregiver is seen as an extension of the patient and their role is not strictly defined, they are informal members of the front-line care team. 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? Sunny White.

Pharma

Pharma Education Transportation Training

Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

MedCity News

SEPTEMBER 28, 2023

The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products. Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency.

FDA

FDA Marketing Patients Biopharma

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

Safety

Safety FDA Patients Biopharma

FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death

MedCity News

JUNE 20, 2023

Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.

Patients

Patients FDA Manufacturing Biopharma

Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

MedCity News

OCTOBER 31, 2023

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease.

Prospecting

Prospecting FDA Patients Biopharma

GSK Gets FDA Nod for Drug Treating Anemia From Chronic Kidney Disease

MedCity News

FEBRUARY 2, 2023

The FDA approved GSK drug Jesduvroq for treating anemia in patients with chronic kidney disease. The once-daily pill is the first oral medicine to pass FDA muster in this indication, giving patients a more convenient alternative to injectable anemia therapies.

FDA

FDA Medicine Patients Biopharma

Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

MedCity News

NOVEMBER 16, 2023

FDA approval of Bristol Myers Squibb’s Augtyro covers treatment of patients whose non-small cell lung cancer is driven by the rare ROS1 mutation. The molecule comes from BMS’s 2022 acquisition of Turning Point Therapeutics.

FDA

FDA Patients Biopharma Pharma

Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

MedCity News

JANUARY 13, 2023

The FDA approved a change in Rybelsus’s label, allowing the drug to be used as an initial therapy for type 2 diabetes patients. The once-daily pill has already become a blockbuster product for Novo Nordisk.

FDA

FDA Patients Biopharma Pharma

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

MedCity News

FEBRUARY 17, 2023

Chiesi drug Lamzede is an engineered version of an enzyme that’s lacking in patients with the rare disease alpha-mannosidosis. FDA approval of the Chiesi drug comes about five years after European regulators authorized the product.

FDA

FDA Engineering Patients Biopharma

Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression

MedCity News

NOVEMBER 18, 2022

Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzeild has received FDA approval for delaying the onset of the most severe stage of this chronic disease.

FDA

FDA Patients Biopharma Pharma

New Hemophilia Data Lead FDA to Delay Decision for BioMarin Gene Therapy

MedCity News

MARCH 7, 2023

BioMarin Pharmaceutical’s submission of additional data for patients treated with its hemophilia A gene therapy, Roctavian, mean that the FDA will push out a regulatory decision to early summer. But it could be worth the wait as analysts anticipate FDA approval and project Roctavian becoming one of BioMarin’s biggest products.

FDA

FDA Leads Pharmaceutical Patients

After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

MedCity News

MAY 30, 2023

Lexicon Pharmaceuticals drug Inpefa is now FDA-approved for heart failure. Inpefa is third in its class, but the biotech says its pill can reach a specific subset of patients, enabling it to stand apart from rival medicines from AstraZeneca and partners Eli Lilly and Boehringer Ingelheim.

FDA

FDA Medicine Pharmaceutical Patients

Myovant Sciences rejects $2.5bn takeover bid from Sumitomo Pharma

Pharmaceutical Technology

OCTOBER 13, 2022

Myovant Sciences has rejected an acquisition offer from Sumitovant Biopharma and its wholly owned subsidiary, Sumitomo Pharma. The drug won its original FDA approval in May last year to treat heavy menstrual bleeding that accompanies uterine fibroids in premenopausal women.

Pharma

Pharma Food and Drug Administration Side effects FDA

FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study

MedCity News

JANUARY 19, 2023

The company said the FDA is asking for data from more patients—results that must come from a larger study that’s underway but won’t report data until later this year. Eli Lilly’s accelerated approval application for its Alzheimer’s disease drug has fallen short.

FDA

FDA Patients Biopharma Pharma

FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review

MedCity News

JANUARY 8, 2023

Eisai Alzheimer’s disease drug Leqembi is now approved for the treatment of patients with an early form of the memory-robbing disease. In granting the antibody accelerated approval, the FDA employed reasoning that was the also basis for the controversial speedy regulatory nod for Biogen’s drug, Aduhelm.

FDA

FDA Patients Biopharma Pharma

InflaRx Covid-19 Drug Welcomes an FDA Win; Pardes Bio Throws In the Towel

MedCity News

APRIL 5, 2023

The FDA granted emergency use authorization to an InflaRx antibody drug that treats hospitalized Covid-19 patients. But Pardes Bioscience’s coronavirus journey is ending following the Phase 2 failure of an antiviral that was expected to compete with Pfizer’s Paxlovid.

FDA

FDA Patients Biopharma Pharma

Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold

MedCity News

APRIL 24, 2023

A clinical trial for a Foghorn Therapeutics cancer drug is under a partial FDA hold after a patient in the early-stage study developed a cardiovascular complication. It’s the biotech’s second partial hold in the past year.

FDA

FDA Leads Patients Biopharma

UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval

MedCity News

JUNE 27, 2023

The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.

FDA

FDA Patients Biopharma Pharma

Biogen bolsters case for ALS drug under FDA review with new published data

MedCity News

SEPTEMBER 22, 2022

A Biogen drug designed for a genetically defined form of amyotrophic lateral sclerosis led to patient improvement at a 12- month analysis, according to data now published in the New England Journal of Medicine.

FDA

FDA Medicine Patients Biopharma

Patient Death Leads to Pause in Test of 2seventy Bio Cell Therapy for Leukemia

MedCity News

JUNE 14, 2023

2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.

Leads

Leads Patients FDA Biopharma

How clinical outcome assessments can help us understand the patient experience

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

Patients

Patients Food and Drug Administration FDA Safety

Eli Lilly Alzheimer’s Drug Meets Phase 3 Goals, Teeing Up Plans for FDA Filing

MedCity News

MAY 3, 2023

Patients treated with Eli Lilly Alzheimer’s disease drug donanemab showed a 35% slowing in decline compared to those given a placebo. Based on the Phase 3 results, Lilly said it would seek FDA approval for the drug by the end of June.

FDA

FDA Patients Biopharma Pharma

Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression

MedCity News

MAY 8, 2024

Last month, Rejoyn became the first FDA-cleared digital therapeutic for patients with depression. Otsuka Pharmaceutical is launching a subsidiary that will commercialize its digital therapeutic Rejoyn — as well as other digital therapeutics and connected health products down the line.

FDA

FDA Pharmaceutical Patients Biopharma

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

FDA

FDA Leads Safety Patients

Embedding the Patient Point of View in Everything You Do

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients

Patients Healthcare Healthcare Marketing

How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

Patients

Patients Pharma Education Media

FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. That leaves three years for pharma companies to prepare. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments.

FDA

FDA Prescription Medicine Biopharma

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

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

Trending Sources

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

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

FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

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

Ipsen beefs up in oncology, buying US biopharma Epizyme

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

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

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

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

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

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

Chiesi expands rare disease portfolio with Amryt Pharma acquisition

J&J multiple myeloma drug gets FDA nod, bringing patients an easier dosing option

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

Reducing real world data lag time for improved patient outcomes

The Caregiver Vertical: How Pharma Engages

Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death

Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

GSK Gets FDA Nod for Drug Treating Anemia From Chronic Kidney Disease

Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression

New Hemophilia Data Lead FDA to Delay Decision for BioMarin Gene Therapy

After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

Myovant Sciences rejects $2.5bn takeover bid from Sumitomo Pharma

FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study

FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review

InflaRx Covid-19 Drug Welcomes an FDA Win; Pardes Bio Throws In the Towel

Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold

UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval

Biogen bolsters case for ALS drug under FDA review with new published data

Patient Death Leads to Pause in Test of 2seventy Bio Cell Therapy for Leukemia

How clinical outcome assessments can help us understand the patient experience

Eli Lilly Alzheimer’s Drug Meets Phase 3 Goals, Teeing Up Plans for FDA Filing

Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

Embedding the Patient Point of View in Everything You Do

How to Work with Patient Advocates, Influencers, and Ambassadors

FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

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