Bio Pharma Dive

FEBRUARY 4, 2022

In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes.

Regulation 294

Regulation Drugs Marketing 294

Bio Pharma Dive

NOVEMBER 17, 2021

A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month

Regulation 324

Regulation Drugs Medicine 324

Fierce Pharma

OCTOBER 13, 2023

Even as Amylyx’s ALS drug gains steam in the U.S. Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

Regulation 107

Regulation FDA Approval Drugs 107

BioPharma Reporter

MARCH 19, 2024

With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.

Regulation 98

Regulation Production Drugs Marketing 98

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 69

Clinical Trials Clinical Trials Regulation Trials 69

Bio Pharma Dive

DECEMBER 16, 2022

The EMA’s drug review committee recommended five new drugs be approved in Europe during its December meeting, including CSL’s Hemgenix, AstraZeneca’s Imjudo and Amicus’ Pombiliti.

Gene Therapy 294

Gene Therapy Regulation Gene Drugs 294

Drug Discovery World

APRIL 29, 2024

In the In Conversation With series, a part of the free DDW podcast, DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. In this episode, Megan Thomas is in conversation with Steve Worland, CEO of eFFECTOR.

Regulation 59

Regulation Gene Scientist Drugs 59

Bio Pharma Dive

DECEMBER 15, 2023

While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclaris, acquired through a recent acquisition, was no sure bet.

Gene Editing 169

Gene Editing Regulation Gene Drugs 169

Bio Pharma Dive

JUNE 23, 2023

An EMA committee expressed concern with the main study meant to show Amylyx’s drug is safe and effective. The company now plans to ask for a re-examination of its approval application.

Regulation 141

Regulation Drugs 141

Bio Pharma Dive

APRIL 20, 2021

Regulators in the U.S. The EMA reiterated the vaccine's benefits outweigh its risks but recommended a warning be added to highlight the rare, but serious side effect. are expected to soon make a similar decision.

Regulation 267

Regulation Vaccination Vaccine Drugs 267

Bio Pharma Dive

JUNE 25, 2021

A key committee of the EMA gave a positive review of Astellas and Fibrogen's roxadustat, as well as Bristol Myers Squibb's cell therapy Abecma and UCB's psoriasis drug Bimzelx.

Regulation 289

Regulation Drugs 289

Bio Pharma Dive

JANUARY 26, 2022

The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals.

Regulation 152

Regulation Drugs Marketing 152

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

Clinical Trials 191

Clinical Trials Clinical Trials Drugs Regulation 191

Drug Discovery World

NOVEMBER 23, 2023

This is the latest episode of the free DDW narrated podcast, “Drug discovery trends: From regulation to embracing AI”, which covers two articles written for Volume 23 – Issue 4, Fall 2022 of DDW. You can also find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts.

Regulation 52

Regulation Drugs 52

ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

Regulation 52

Regulation Marketing Drugs Research 52

Fierce Pharma

APRIL 12, 2024

Eight months after the European Medicines Agency (EMA) opened an investigation into a potential link between popular GLP-1 receptor agonists and suicidal thoughts or actions, the agency has determi | The regulators began investigating meds in the GLP-1 drug class for a potential association in July after two reported cases of suicidal thoughts and (..)

Regulation 67

Regulation Medicine Drugs 67

Bio Pharma Dive

JANUARY 11, 2024

As a result of the planned consultation, Eisai now expects an approval decision on Leqembi in Europe by the end of June, rather than March.

Regulation 161

Regulation Drugs 161

Bio Pharma Dive

MAY 1, 2024

The move broadens the antitrust regulator’s campaign against allegedly “improper or inaccurate” patent listings by drugmakers to include top-selling medicines for weight loss, diabetes, asthma and COPD.

Regulation 152

Regulation Drugs Medicine 152

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Proposed Amendments.

Regulation 98

Regulation Drugs Manufacturing Production 98

Pharmaceutical Technology

APRIL 18, 2023

Three regulators in different jurisdictions have accepted Bristol Myers Squibb’s applications for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients.

Regulation 130

Regulation Gene Therapy Gene Development 130

Scienmag

JUNE 29, 2022

Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of new medicines before they hit the market. Over […].

Regulation 67

Regulation Drugs Doctors Doctor 67

STAT News

DECEMBER 6, 2022

France’s drug regulator is being investigated for issuing misleading information in connection with a thyroid treatment sold by Merck KGaA, and the move comes just weeks after an investigation was also opened into the company over the same allegation. Continue to STAT+ to read the full story…

Regulation 98

Regulation Drugs Medicine Development 98

Bio Pharma Dive

NOVEMBER 11, 2022

Once the European Commission signs off, use of several so-called JAK inhibitors sold by Eli Lilly, Pfizer and other drugmakers will be limited among smokers and patients who are at high risk of certain health complications.

Regulation 162

Regulation Drugs 162

Bio Pharma Dive

JULY 12, 2023

The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.

Drugs 245

Drugs Regulation Medicine 245

BioSpace

MAY 29, 2023

European Regulator Leaning Toward Rejecting Amylyx’s ALS Drug 5/30/2023

Regulation 73

Regulation Drugs 73

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

Regulation 155

Regulation Drugs Licensing Licensing 155

Bio Pharma Dive

OCTOBER 28, 2022

The new recommendations could further curtail the use of so-called JAK inhibitors, though the restrictions imposed in Europe are less severe than they are in the U.S.

Regulation 269

Regulation Drugs 269

STAT News

DECEMBER 15, 2022

and European regulators on Thursday to adopt new standards for approving antibody drugs against Covid, particularly for immunocompromised and other vulnerable patients. Biotech executives and a handful of academics pleaded with U.S.

Regulation 98

Regulation Antibody Drugs Development 98

XTalks

FEBRUARY 26, 2024

The food industry is poised for significant changes in 2024 thanks to the US Food and Drug Administration (FDA), legislative turbulence and the active role of government agencies and advocacy groups. Key developments in food regulations in 2024 are expected, focusing on safety, transparency and public health.

Regulation 59

Regulation Compliance Production Development 59

FDA Law Blog

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

Regulation 64

Regulation Drugs Production Research 64

pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. Personal approach. Here to listen. About the author.

Regulation 105

Regulation Development Drugs Clinical Trials 105

Bio Pharma Dive

SEPTEMBER 1, 2021

The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors.

Regulation 300

Regulation Drugs 300

Bio Pharma Dive

DECEMBER 12, 2023

Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.”

Licensing 298

Licensing Licensing Regulation Research 298

pharmaphorum

APRIL 23, 2021

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . Amarin said that Vazkepa is one of the first drugs filed and licensed through the MHRA’s new “Reliance” route following the end of the Brexit transition period.

Cardiology 98

Cardiology Regulation Drugs Licensing 98

Bio Pharma Dive

JULY 26, 2022

Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.

Drugs 321

Drugs Protein Regulation Research 321

STAT News

NOVEMBER 15, 2022

Antitrust regulators in Spain have fined a drugmaker $10.6 But the drug was bought by Leadiant Biosciences which, by 2014, began raising the price in several countries before withdrawing the medicine from the market entirely the following year. There was a low-cost version available for decades.

Regulation 98

Regulation Drugs Genetics Medicine 98

Fierce Pharma

JANUARY 26, 2024

Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of a marketing authorization | Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of marketing authorization for Apellis’ geographic atrophy (GA) drug Syfovre (pegcetacoplan injection), the company said it will (..)

Regulation 90

Regulation Drugs Medicine Production 90