MedCity News

SEPTEMBER 30, 2022

An Amylyx Pharmaceuticals drug developed to slow the progression of amyotrophic lateral sclerosis is now approved, making it just the third FDA-approved treatment for the disease. Amylyx will market its new product under the name “Relyvrio.”.

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pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. is to acquire the 2015-established Amryt Pharma Plc. Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 on 6 th January.

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MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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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.

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MedCity News

MAY 19, 2023

Bausch + Lomb drug Miebo is now FDA approved as a new treatment for dry eye disease. Unlike many products that rewet the eye, Miebo is designed to address one of the factors that leads to dry eyes.

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MedCity News

JULY 18, 2023

Novartis’s acquisition of DTx Pharma brings a lead program for a rare disease with no FDA-approved therapies. But the deal could also help the pharma giant bring new RNA therapies to new places in the body, a top Novartis executive explained.

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MedCity News

FEBRUARY 21, 2023

Travere Therapeutics drug Filspari won accelerated FDA approval to treat a rare disorder that can lead to kidney failure. The small molecule is also in late-stage testing for another rare kidney disease; analysts say each indication represents a blockbuster opportunity.

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pharmaphorum

DECEMBER 16, 2022

The Japanese pharma says it will now start talking to regulatory authorities around the world about potential marketing applications for zolbetuximab as a first-line treatment for patients with locally advanced unresectable or metastatic gastric and gastro-oesophageal (GEJ) cancer. Claudin 18.2 Other companies developing claudin 18.2-targeted

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MedCity News

JUNE 14, 2023

The FDA has been notified and an investigation is underway. 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.

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Clarivate

JANUARY 23, 2024

While some industry observers read this drop as a clear decline in productivity, others take a more optimistic view, attributing the decline to FDA submission calendar fluctuations and noting that 2022 numbers were not very different from the ten-year average. In fact, the number of NMEs has grown by 65% between 2013 and 2022.

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MedCity News

JANUARY 21, 2024

The FDA said Amgen’s Prolia may lead to low levels of calcium, or hypocalcemia.

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MedCity News

FEBRUARY 17, 2023

The FDA approved Apellis Pharmaceuticals’ Syfovre as a treatment for geographic atrophy, a retinal disorder that is a leading cause of blindness. The drug, administered as an injection into the eye, will launch in March at the price of $2,190 per vial.

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MedCity News

OCTOBER 21, 2022

based biotech’s lead program is an antibody drug in preclinical development for idiopathic pulmonary fibrosis, a chronic lung disorder with few FDA-approved treatments. AbbVie acquired DJS Antibodies for $255 million up front.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

On 23 August, at a Reuters Newsmakers online forum, Soriot announced his interest in increasing AstraZeneca’s portfolio of bolt-on acquisitions leading up to 2025. The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June. In 2019, AstraZeneca entered a $6.9

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Pharmaceutical Technology

APRIL 4, 2023

While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024. Up to 12.5%

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PM360

DECEMBER 14, 2023

Moderna Joins CEPI Pandemic Preparedness Mission After making its debut in the pharma market during the COVID-19 pandemic, Moderna is preparing for the next pandemic. The pharma company has joined the Coalition for Epidemic Preparedness Innovations (CEPI) in a partnership that aims to shorten vaccine development timelines down to 100 days.

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PM360

MAY 2, 2023

We are fortunate to work with innovative startup and mid-stage biopharma companies that are developing vaccines and medicines for rare diseases, cancer, specialty therapeutic areas, and other patient needs, as well as partnering with diagnostic and medical device companies.

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pharmaphorum

DECEMBER 20, 2022

The road to the development of treatments for non-alcoholic steatohepatitis (NASH) is littered with failed projects, but US biotech Madrigal Pharma thinks it now has enough evidence for its drug resmetirom to support regulatory filings. Although, so far efforts to bring a therapy to market have failed.

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pharmaphorum

SEPTEMBER 30, 2022

Perhaps more interestingly, similar signals have also emerged from traditional biopharma heavyweights, such as Novartis and Lilly, which one would typically associate with more conservative approaches to pricing. He works across multiple therapeutic areas for pharma, biotech, and medical device companies.

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pharmaphorum

SEPTEMBER 13, 2022

The HARMONY study compared two doses of Akero’s FGF21 mimic efruxifermin to placebo over 24 weeks in 128 adult patients with biopsy-confirmed NASH, a serious form of non-alcoholic fatty liver disease (NAFLD) that affects millions of people and which for several years has been billed as one of pharma’s next big growth areas.

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Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

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Clarivate

NOVEMBER 13, 2023

More recently, the FDA has developed the Patient Focused Drug Development (PFDD) Guidance Series, which provides sponsors with guidance on how to collect and submit patient experience data in medical product development for regulatory decision making. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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Clarivate

NOVEMBER 10, 2022

The evidence standards that a COA must meet to support key clinical trial endpoints have become increasingly stringent in recent decades, following the introduction of the United States Food and Drug Administration (FDA) Patient Reported Outcomes (PRO) draft guidance in 2006, followed by the full guidance in 2009.

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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. Patients want to know other patients are involved in what pharma is doing. Learn how pharma is involving them. They want to hear about those patients’ experiences.

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PM360

SEPTEMBER 15, 2022

Quantitative survey results can often lead to a false sense of security around pre-selected response options, therefore missing critical contextual information that helps someone truly understand the patient’s perspective. This sub-set of office personnel is valuable and often leads to rich insights if marketers can spend the time/money.

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European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.

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Clarivate

NOVEMBER 8, 2022

Beyond these household names there is an entire world of innovator companies – plucky startups and well-resourced large pharmas alike – looking to leverage this emerging technology to treat and even cure a wide variety of diseases. . Cargene Biopharma Inc., DTx Pharma Inc., Aro Biotherapeutics , a Philadelphia, U.S.

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Clarify Health

MAY 19, 2020

After FDA-approval comes the last critical mile of this journey: bringing the product to market. There is also a looming, time-sensitive reality that biopharma companies face once their products hit the market: they need to recoup the costs of development as quickly as possible before drug patents expire and generics threaten sales.

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Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Key ESMO findings. months; HR: 0.321, P<0.001).

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Pharmaceutical Technology

MAY 24, 2023

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. This major difference leads to very different requirements and processes for the clinical trial supply chain, which are summarized below.

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