Development - Clinical Research Informer

US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

MARCH 8, 2023

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The regulatory approval marks the company’s first product to receive approval in the US market.

FDA Approval

FDA Approval Drugs Production Development

FDA approves first-of-its-kind lupus drug

Bio Pharma Dive

JANUARY 25, 2021

Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.

FDA Approval

FDA Approval Drugs Development

Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug

Pharmaceutical Technology

NOVEMBER 22, 2022

The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted emergency regulatory approval for Shionogi ’s new anti-SARS-CoV-2 drug, Xocova (ensitrelvir fumaric acid, S-217622), for Covid-19. It is the first such drug to receive approval under the new emergency approval system.

Drugs

Drugs Clinical Trials Clinical Trials Sales

FDA advisers back new endpoint for myeloma approvals, paving way for faster introduction of new drugs

Fierce Pharma

APRIL 12, 2024

After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey.

Drugs

Drugs Development

Do patients care about accelerated approval drugs?

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

Drugs

Drugs Doctors Doctor Marketing

New Drug Approval for in-House Developed Anti-Insomnia Drug Dayvigo (Lemborexant) in Hong Kong

Pharma Mirror

MARCH 2, 2021

has obtained approval for the in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. This approval is the first approval for DAYVIGO in Asia outside of Japan.

Development

Development Drugs Regulation

China’s NMPA conditionally approves two oral drugs for Covid-19

Pharmaceutical Technology

JANUARY 29, 2023

The National Medical Products Administration (NMPA) of China has granted conditional approval for two domestically developed oral drugs to treat Covid-19. Simcere Pharmaceutical Group and Shanghai Junshi Biosciences’ subsidiary have submitted the applications for the two drugs Xiannuoxin (SIM0417) and VV116, respectively.

Drugs

Drugs Clinical Trials Clinical Trials Trials

ALS drug approved by FDA in closely watched decision, marking win for patients, developer

Bio Pharma Dive

SEPTEMBER 30, 2022

The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.

Drugs

Drugs Development

Transforming drug development with AI

pharmaphorum

FEBRUARY 14, 2024

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

Development

Development FDA Approval Drugs Compliance

Novartis gets FDA approval of closely watched rare disease drug

Bio Pharma Dive

DECEMBER 6, 2023

The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.

FDA Approval

FDA Approval Drugs Development

FDA approves Sanofi’s long-lasting hemophilia drug

Bio Pharma Dive

FEBRUARY 23, 2023

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

FDA Approval

FDA Approval Drugs Protein Marketing

AbbVie removes two approvals for blood cancer drug Imbruvica

Bio Pharma Dive

APRIL 7, 2023

In paring back use of Imbruvica, the drugmaker has become the latest developer to voluntarily withdraw indications for a cancer medicine following a setback in confirmatory testing.

Medicine

Medicine Drugs Development

Mission Therapeutics moves kidney disease drug to phase 2 after FDA approval

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval

FDA Approval Drugs Trials Development

Novel drug approvals declined in 2022 but what are the CMO opportunities in 2023?

Pharmaceutical Technology

MARCH 27, 2023

In 2022, the US FDA disappointingly approved almost a third fewer of the most innovative drugs than it did in 2021. During 2013–2022, NME approvals were lower only in 2013 and 2016. Faced with such a disappointing approval number last year, manufacturers hope for more NMEs to enter the market in 2023.

Drugs

Drugs FDA Approval Manufacturing Production

Decline of novel drug approvals means less business for cutting-edge CMOs

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

Drugs

Drugs Manufacturing Contract Manufacturing FDA Approval

FDA approves first microbiome drug from Ferring Pharmaceuticals

STAT News

NOVEMBER 30, 2022

The Food and Drug Administration approved the first therapy using bacteria from stool samples to treat a bowel disorder on Wednesday, paving the way for several similar treatments in development. The drug, called Rebyota, is given as a one-dose treatment for clostridium difficile infection s, commonly known as C.

FDA Approval

FDA Approval Bacteria Drugs Development

FDA approves new RSV drug to protect infants, toddlers

Bio Pharma Dive

JULY 17, 2023

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

FDA Approval

FDA Approval Antibody Drugs Development

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

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That leaves three years for pharma companies to prepare.

Drugs

Drugs Regulation Gene Therapy Insulin

Merck and Orion enter partnership to develop ODM-208 for prostate cancer

Pharmaceutical Technology

JULY 13, 2022

Merck (MSD outside North America) and Orion have entered an international agreement to develop and market the latter’s investigational candidate ODM-208 to treat metastatic castration-resistant prostate cancer (mCRPC). Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer.

Development

Development Hormones Production Marketing

As BI-1361849 moves closer to clinical approval, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

JANUARY 2, 2023

BI-1361849 is under clinical development by Boehringer Ingelheim International and currently in the Phase II in clinical pathway. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their BI-1361849 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Drugs

Drugs Production Manufacturing Development

US FDA launches lupus consortium to confront drug development challenges

Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Asian, Hispanic, and Native American women are also at higher risk.

Development

Development Drugs FDA Approval Clinical Development

Fierce Pharma Asia—AstraZeneca's GLP-1 play; Takeda's cancer drug approval; BioNTech's bispecific deal

Fierce Pharma

NOVEMBER 9, 2023

Takeda won FDA approval for the Hutchmed-developed colorectal cancer drug Fruzaqla. Takeda won FDA approval for Hutchmed-developed colorectal cancer drug Fruzaqla. AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene.

FDA Approval

FDA Approval Licensing Licensing Drugs

Medincell, AbbVie link up in long-acting injectable development pact worth up to $1.9B

Fierce Pharma

APRIL 17, 2024

After proving the merits of its drug delivery platform last year with the approval of Teva’s long-acting schizophrenia drug Uzedy, France’s Medincell has hooked another big-name partner. Medincell and AbbVie inked a development and licensing pact to create up to six long-acting injectables, Medincell said Wednesday.

Development

Development Drug Delivery Licensing Licensing

Danicamtiv, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Danicamtiv Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Drugs

Drugs Pharmacy Production Development

EMA upgrades drug development innovation scheme to PRIME time

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. Last year, the EMA approved 49 new medicines , of which eight were recommended for approval through the PRIME scheme.

Development

Development Drugs Medicine Production

Which drugs are most likely to be approved in Pneumonia?

Pharmaceutical Technology

MARCH 27, 2024

Pneumonia disease is an indication for drug development with over 230 pipeline drugs currently active according to GlobalData.

Drugs

Drugs Development

Which drugs are most likely to be approved in Cough?

Pharmaceutical Technology

MARCH 27, 2024

Cough disease is an indication for drug development with over 40 pipeline drugs currently active according to GlobalData.

Drugs

Drugs Development

Lifirafenib maleate, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lifirafenib maleate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Drugs

Drugs Development Clinical Trials Clinical Trials

Mission Therapeutics moves kidney disease drug to phase 2 after FDA approval

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval

FDA Approval Drugs Trials Development

Which drugs are most likely to be approved in Respiratory Tract Infections?

Pharmaceutical Technology

MARCH 27, 2024

Respiratory Tract Infections disease is an indication for drug development with over 120 pipeline drugs currently active according to GlobalData.

Drugs

Drugs Development

STAT+: In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

STAT News

SEPTEMBER 8, 2022

At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. Continue to STAT+ to read the full story…

Drugs

Drugs Development

In the News: August 2021 Regulatory and Development Updates

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. Some Drugs May Require Reclassification to Devices. Genus succeeded in both the District and Appellate courts.

Development

Development Regulation Production Drugs

Lilly agrees to acquire gene therapy developer Akouos for $610m

Pharmaceutical Technology

OCTOBER 19, 2022

Akouos focuses on developing adeno-associated viral gene therapies to treat inner ear conditions, including sensorineural hearing loss. It has combined expertise in otology, gene therapy and inner ear drug delivery to meet the requirements of individuals with disabling hearing loss globally.

Gene Therapy

Gene Therapy Gene Development Genetics

Which drugs are most likely to be approved in Cryopyrin-Associated Periodic Syndromes?

Pharmaceutical Technology

MARCH 27, 2024

Cryopyrin-Associated Periodic Syndromes disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.

Drugs

Drugs Development

Which drugs are most likely to be approved in Complicated Intra-Abdominal Infections?

Pharmaceutical Technology

MARCH 27, 2024

Complicated Intra-Abdominal Infections disease is an indication for drug development with over 20 pipeline drugs currently active according to GlobalData.

Drugs

Drugs Development

Which drugs are most likely to be approved in Labor And Delivery?

Pharmaceutical Technology

MARCH 27, 2024

Labor And Delivery disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.

Drugs

Drugs Development

In the News: October Regulatory and Development Updates

Camargo

NOVEMBER 11, 2020

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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development

Development Bioequivalency Generic Drugs Production

Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs

Drugs FDA Approval Sales Vaccination

FDA approves Takeda's metastatic colorectal cancer drug

Outsourcing Pharma

NOVEMBER 13, 2023

A small molecule, oral targeted therapy for adults with metastatic colorectal cancer (CRC) has been approved by the US Food and Drug Administration (FDA).

FDA Approval

FDA Approval Drugs Clinical Development Development

Streamlining healthcare with AI for drug development

Pharmaceutical Technology

JUNE 15, 2023

AI for drug development is rapidly streamlining R&D processes, speeding up time to market and providing a better experience for patients and providers. Learn more about the role of AI in drug development and how healthcare researchers are using it to shake up the field.

Development

Development Drugs Clinical Trials Clinical Trials

STAT+: FDA advisory panel recommends conditional approval of Biogen’s drug for rare form of ALS

STAT News

MARCH 22, 2023

An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients. Continue to STAT+ to read the full story…

Drugs

Drugs Clinical Trials Clinical Trials Genetics

Roche's subcutaneous answer to AstraZeneca PNH drugs wins world-first approval in China

Fierce Pharma

FEBRUARY 8, 2024

China has become the first country to sign off on Roche’s paroxysmal nocturnal hemo | China has become the first country to sign off on Roche’s paroxysmal nocturnal hemoglobinuria (PNH) drug crovalimab, a subcutaneous answer to AstraZeneca’s infused treatments Soliris and Ultomiris.

Drugs

Drugs Antibody Development

Telix revives Olaratumab development with positive preclinical data

Pharmaceutical Technology

APRIL 17, 2023

Telix has announced the successful preclinical development of radiolabelled olaratumab, an antibody licensed by Eli Lilly and Company. Olaratumab will be denoted as TLX300 in Telix’s development pipeline. But, following negative Phase III efficacy results, Lilly withdrew the drug from the market.

Development

Development Antibody Pharma Companies Licensing

In the News: April 2021 Regulatory and Development Updates

Camargo

MAY 10, 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. FDA’s Accelerated Approval Program Comes Under Fire. Drug Product. Committee Vote on Whether to Maintain Approval. Indication.

Development

Development Clinical Trials Clinical Trials Trials

US FDA approves Shorla’s oncology drug for T-cell leukaemia

FDA approves first-of-its-kind lupus drug

Trending Sources

Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug

FDA advisers back new endpoint for myeloma approvals, paving way for faster introduction of new drugs

Do patients care about accelerated approval drugs?

New Drug Approval for in-House Developed Anti-Insomnia Drug Dayvigo (Lemborexant) in Hong Kong

China’s NMPA conditionally approves two oral drugs for Covid-19

ALS drug approved by FDA in closely watched decision, marking win for patients, developer

Transforming drug development with AI

Novartis gets FDA approval of closely watched rare disease drug

FDA approves Sanofi’s long-lasting hemophilia drug

AbbVie removes two approvals for blood cancer drug Imbruvica

Mission Therapeutics moves kidney disease drug to phase 2 after FDA approval

Novel drug approvals declined in 2022 but what are the CMO opportunities in 2023?

Decline of novel drug approvals means less business for cutting-edge CMOs

FDA approves first microbiome drug from Ferring Pharmaceuticals

FDA approves new RSV drug to protect infants, toddlers

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

Merck and Orion enter partnership to develop ODM-208 for prostate cancer

As BI-1361849 moves closer to clinical approval, what is the likelihood that the drug will be approved?

US FDA launches lupus consortium to confront drug development challenges

Fierce Pharma Asia—AstraZeneca's GLP-1 play; Takeda's cancer drug approval; BioNTech's bispecific deal

Medincell, AbbVie link up in long-acting injectable development pact worth up to $1.9B

Danicamtiv, what is the likelihood that the drug will be approved?

EMA upgrades drug development innovation scheme to PRIME time

Which drugs are most likely to be approved in Pneumonia?

Which drugs are most likely to be approved in Cough?

Lifirafenib maleate, what is the likelihood that the drug will be approved?

Mission Therapeutics moves kidney disease drug to phase 2 after FDA approval

Which drugs are most likely to be approved in Respiratory Tract Infections?

STAT+: In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

In the News: August 2021 Regulatory and Development Updates

Lilly agrees to acquire gene therapy developer Akouos for $610m

Which drugs are most likely to be approved in Cryopyrin-Associated Periodic Syndromes?

Which drugs are most likely to be approved in Complicated Intra-Abdominal Infections?

Which drugs are most likely to be approved in Labor And Delivery?

In the News: October Regulatory and Development Updates

Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

FDA approves Takeda's metastatic colorectal cancer drug

Streamlining healthcare with AI for drug development

STAT+: FDA advisory panel recommends conditional approval of Biogen’s drug for rare form of ALS

Roche's subcutaneous answer to AstraZeneca PNH drugs wins world-first approval in China

Telix revives Olaratumab development with positive preclinical data

In the News: April 2021 Regulatory and Development Updates

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