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

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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.

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Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

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Pharmaceutical Technology

MARCH 11, 2024

Macau has accepted a NDA of Everest Medicines for VELSIPITY, a treatment for adults with active ulcerative colitis (UC).

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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 (..)

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ProRelix Research

DECEMBER 14, 2023

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European […] The post EMA Pharmacovigilance Regulations Updates appeared first on ProRelix Research.

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Pharmaceutical Technology

FEBRUARY 27, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorisation for Me rck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir). Merck and Ridgeback intend to appeal the decision and request a re-examination of the regulator’s opinion.

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World of DTC Marketing

FEBRUARY 21, 2022

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. ” More checks from PhRMA to politicians are coming up.

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Pharma in Brief

DECEMBER 23, 2021

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until July 1, 2022. The amendments to the Regulations contain a number of changes affecting the PMPRB’s review of patented medicine prices. The amendments.

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Bio Pharma Dive

DECEMBER 16, 2021

The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.

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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.

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Pharma in Brief

APRIL 25, 2021

These amendments permit patents claiming different forms of a medicinal ingredient (e.g., different salt forms) of the medicinal ingredient in comparison to the Canadian Reference Product (“ CRP ”). Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections.

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Bio Pharma Dive

OCTOBER 2, 2023

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

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Outsourcing Pharma

MARCH 26, 2024

Under the agreement, Closed Loop Medicine â a leading TechBio company â and pharmaceutical company, Teva UK, will investigate opportunities to use Closed Loop Medicineâs proprietary software as a medical device (SaMD) technology platform.

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pharmaphorum

AUGUST 17, 2021

Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report. The post Global regulators seek permanent working group on AI appeared first on.

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Pharma in Brief

DECEMBER 8, 2022

On December 5, 2022, the Federal Court of Appeal ( FCA ) upheld the validity of changes to the list of countries used for international reference pricing by the Patented Medicine Prices Review Board ( PMPRB ). The FCA rejects a hyperdeferential standard of review for regulations. The FCA affirms statutory limits on the PMPRB.

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Scienmag

JUNE 29, 2022

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

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Drug Discovery World

MARCH 23, 2023

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. The post Biggest overhaul of UK clinical trial regulation for 20 years appeared first on Drug Discovery World (DDW).

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STAT News

NOVEMBER 15, 2022

Antitrust regulators in Spain have fined a drugmaker $10.6 million for years of “excessive” price hikes on a rare disease medicine, the latest instance in which European authorities have cracked down on the pharmaceutical industry for harming consumers and taxpayers. There was a low-cost version available for decades.

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pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on. . The healthcare charity is providing £1.8

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Bio Pharma Dive

AUGUST 25, 2023

market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.

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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 (..)

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Drug Discovery World

FEBRUARY 7, 2024

It is also under review with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The post Japanese regulator reviews first-line bladder cancer combination appeared first on Drug Discovery World (DDW). The US Food and Drug Administration approved the combination therapy in December 2023.

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Bio Pharma Dive

AUGUST 17, 2022

The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.

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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.

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Bio Pharma Dive

OCTOBER 3, 2022

The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.

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BioPharma Reporter

MARCH 26, 2024

Teva UK and Closed Loop Medicine have announced a strategic partnership to advance the development of personalized medicine.

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BioTech 365

DECEMBER 9, 2020

Olainfarm medicines reach patients in Russia according to new medication verification regulations Olainfarm medicines reach patients in Russia according to new medication verification regulations Olainfarm medicines are successfully reaching patients in Russia.

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Fierce Pharma

NOVEMBER 10, 2023

Mirati Therapeutics’ KRAS inhibitor Krazati’s EU prospects weren’t looking good after an initial rejection from Europe's drugs regulator.

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Pharma in Brief

JULY 7, 2021

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until January 1, 2022. The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices.

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Bio Pharma Dive

DECEMBER 17, 2021

The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks."

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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. The German drug maker had phased out an earlier formulation a few months earlier.

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pharmaphorum

DECEMBER 19, 2022

The recommendations are part of the ACT EU initiative between the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) group – launched earlier this year – intended to further develop the EU’s role as a centre for clinical research.

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Drug Discovery World

OCTOBER 16, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. The post UK regulator cuts late-stage clinical trial approval time to two weeks appeared first on Drug Discovery World (DDW).

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Drug Discovery World

SEPTEMBER 8, 2023

Approval has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech Covid-19 vaccine that targets the Omicron XBB 1.5 The European Commission’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug for approval in the EU in August. subvariant. 1.16, and XBB.2.3,

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pharmaphorum

MARCH 11, 2021

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. “And right now we need all the vaccines we can get.

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Bio Pharma Dive

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

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