Bio Pharma Dive

OCTOBER 8, 2023

Mirati shareholders could also receive another $1 billion should an experimental cancer drug the biotech is developing make it to U.S. regulators’ desks.

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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. The rise of patient centricity. “We Personal approach.

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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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Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. This includes an upfront payment of $2m from AstraZeneca.

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Pharmaceutical Technology

NOVEMBER 1, 2023

Kite has signed agreement with Epic Bio for the development of new cancer cell therapies leveraging the latter’s gene regulation platform.

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XTalks

FEBRUARY 26, 2024

Key developments in food regulations in 2024 are expected, focusing on safety, transparency and public health. For stakeholders in the food industry, understanding and adapting to these regulations is not just a matter of compliance but a strategic imperative for business success. 3 and brominated vegetable oil.

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World of DTC Marketing

FEBRUARY 21, 2022

didn’t just offer to pay for the drug’s development cost so that the price could be set very low, but it’s about investors who penalized the company stock when they learned that COVID might be on the decline. The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com.

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Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

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FDA Law Blog

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” They believe any regulatory oversight for laboratory developed tests (LDTs) should be mandated by Congress, rather than the Executive Branch.

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Pharma Times

OCTOBER 27, 2023

The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes

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Rethinking Clinical Trials

APRIL 24, 2024

Matthew Semler In this Friday's PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present "Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape."

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FDA Law Blog

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. By Jeffrey N. Gibbs & Steven J.

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BioSpace

MAY 31, 2021

regulator may be able to be commercialized without the black-box warnings that accompany so many TNF-? MyMD Pharmaceuticals’ TNF-? therapies.

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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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Camargo

SEPTEMBER 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”.

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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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Pharmaceutical Technology

SEPTEMBER 9, 2022

US-based biotech company Gatehouse Bio is extending its collaboration with AstraZeneca for developing RNA therapeutics to treat heart failure with preserved ejection fraction (HFpEF). It is expected to expedite the development of a wide range of new therapeutics using the small non-coding area of the genome that is not explored.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 4, 2023

The Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) may soon undertake development of pharmacopoeia standards for the Ayurveda, Siddha, Unani and Homoeopathy drugs under the ‘One Herb One Standard’ (OHOS) among other initiatives during the financial year 2023-24.

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FDA Law Blog

JUNE 14, 2021

Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. This step would help propel forward a public conversation (which CMS has already started ) about how to update these regulations in light of technological advances.

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Medical Xpress

MAY 9, 2023

An international group of doctors and public health experts have joined the clamor for a moratorium on AI research until the development and use of the technology are properly regulated.

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Doctors Doctor Regulation Development 94

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

The CMAs of the company can lower fat throughout the body through mitochondrial uncoupling, a natural process that causes energy regulation. The post Rivus raises $132m to advance clinical development of obesity treatment appeared first on Pharmaceutical Technology.

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STAT News

OCTOBER 12, 2022

— Biotech companies developing cutting-edge cell and gene therapies often are tripped up by how much regulations around these drugs vary from country to country. On Wednesday, regulators from the United States, the European Union, and Japan came together to discuss the scale of the problem — and possible solutions.

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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STAT News

OCTOBER 19, 2022

In the rapidly changing landscape of digital health, innovation has often outpaced regulations , especially for novel technologies and emerging industries. To this end, the FDA has been testing new regulatory paradigms , modernizing submission approaches , updating policies , and urging legislative actions to keep up with new developments.

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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.

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Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Q32 will also receive tiered royalty payments on net sales.

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Medical Xpress

APRIL 24, 2023

Iron is important for life, and iron deficiency impairs development, but whether the iron level regulates neural differentiation remains elusive. Iron-regulatory proteins (IRPs), including IRP1 and IRP2, are the major regulators of cellular iron homeostasis.

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Pharmaceutical Technology

MAY 19, 2023

SiteOne Therapeutics has received a $15m grant from the National Institute on Drug Abuse (NIDA) to develop the investigational selective NaV1.8 Titled ‘Development of a potent and selective Nav1.8 The company stated that the grant from NIDA will support the clinical development of its NaV1.8

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pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on.

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Pharmaceutical Technology

APRIL 5, 2023

PRIME is an EMA scheme to support the development of medicines for rare diseases and conditions with high unmet need. The scheme also supported the development of thirteen treatments across several therapy areas last year. Breyanzi is a treatment for various lymphomas and Carvykti is an orphan medicine for multiple myeloma.

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Drug Discovery World

FEBRUARY 7, 2024

The post Japanese regulator reviews first-line bladder cancer combination appeared first on Drug Discovery World (DDW). It is estimated that approximately 25,000 people in Japan are diagnosed with bladder cancer each year and approximately 10,000 deaths were reported in 2022.

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Scienmag

MAY 6, 2021

Jude Children’s Research Hospital scientists have developed a highly efficient method to address a major challenge in biology–identifying the genetic ‘switches’ that regulate gene expression. Credit: St. Jude Children’s Research Hospital St.

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STAT News

SEPTEMBER 26, 2022

Regulators in half a dozen European countries are now taking steps to enforce requirements that clinical trial sponsors make study results public, although three other countries have so far taken little to no action, a new analysis finds. Continue to STAT+ to read the full story…

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Medical Xpress

APRIL 3, 2023

Among the health problems developed or aggravated by COVID-19, those that affect neurological and respiratory functions draw special attention from specialists.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

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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.

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