Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. Why has there been so little progress in medicine? Why has it been so unproductive?

Medicine 59

Medicine Genome Genomics Drugs 59

Drug Discovery World

SEPTEMBER 4, 2023

In the third and final part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates therapeutic breakthroughs using plant-based products in drug discovery. The team also identified other molecules that can also untangle tau and may be better drug candidates than the green tea molecule.

Medicine 59

Medicine Protein Containment Drugs 59

Pharma in Brief

APRIL 25, 2021

These amendments permit patents claiming different forms of a medicinal ingredient (e.g., As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,

Regulation 98

Regulation Medicine Generic Drugs Containment 98

Pharma in Brief

AUGUST 5, 2020

DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. The Minister determined that TAF is a new chemical entity first approved in another Gilead drug product GENVOYA. Because DESCOVY contains TAF, it benefits from the same data protection term granted to GENVOYA. Background.

Containment 52

Containment Drugs Regulation Medicine 52

FDA Law Blog

OCTOBER 19, 2022

Houck — If, as Albert Einstein supposedly quipped, a cluttered desk is the sign of a cluttered mind, what then does a cluttered medicine cabinet signify? More than a mere sign, a cluttered medicine cabinet can be hazardous if it contains unneeded and expired prescription medication susceptible to theft, misuse and abuse.

Medicine 45

Medicine Containment Drugs 45

pharmaphorum

JANUARY 20, 2022

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin. This works to ensure the safety and efficacy of the drugs received by patients.

Drugs 109

Drugs Medicine Containment Branding 109

STAT News

DECEMBER 12, 2022

The Food and Drug Administration on Monday approved a second KRAS-blocking treatment for advanced lung cancer. However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results.

FDA Approval 98

FDA Approval Sales Drugs Clinical Trials 98

FDA Law Blog

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. In late2023, CVM issued nine Warning Letters to distributors of veterinary products for use in aquarium fish and birds.

Drugs 59

Drugs Production Licensing Licensing 59

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.

Regulation 72

Regulation Medicine Containment Life Science 72

Drug Discovery World

APRIL 12, 2024

The cancer research news has been coming thick and fast from the American Association of Cancer Research (AACR) Annual Meeting in San Diego this week, so our Friday round-up focuses on drug discovery in oncology. The post This week in drug discovery (8-12 April) appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs Genetic Engineering Immune Response Engineer 52

Drug Discovery World

FEBRUARY 6, 2023

Mesoblast has resubmitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Medicine 52

Medicine FDA Approval Licensing Licensing 52

Medical Xpress

DECEMBER 2, 2022

Cough medicines containing the chemical pholcodine should be banned due to the risk of potentially deadly allergic reactions in people under general anaesthetic, the European Union's drug regulator said Friday.

Allergies 96

Allergies Containment Regulation Medicine 96

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

Packaging 130

Packaging Packaging Marketing Containment 130

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. GDP and GMP advisory.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

Druggist

MARCH 23, 2021

Ibuprofen is one of the most common drugs purchased over the counter in the UK. Ibuprofen prescribing decreased significantly in recent years due to the NHS strategy to minimise issuing of medicines that are available over the counter. Today I will review ibuprofen alternative drugs. Other alternative drugs to ibuprofen.

Drugs 92

Drugs Pharmacy Branding Containment 92

Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

Medicine 52

Medicine Scientist Production Regulation 52

Pharmaceutical Technology

DECEMBER 27, 2022

Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). The company stated that Nirmacom is a generic version of Pfizer ’s Covid-19 oral antiviral drug, Paxlovid, a SARS-CoV-2 main protease (Mpro) inhibitor.

Licensing 195

Licensing Licensing Containment Medicine 195

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).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

Drug Discovery World

JANUARY 9, 2024

Thirteen new-to-market therapeutics and drugs poised to launch in 2024 will achieve ‘blockbuster’ status by 2029 or deliver game-changing benefits to patients. The 2024 Drugs to Watch, are: 1.

Drugs 69

Drugs Antibody Gene Editing Medicine 69

pharmaphorum

MAY 4, 2022

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. The limits of animal models in drug discovery are well known. Organ-on-a-chip.

Drugs 142

Drugs Licensing Licensing Pharma Companies 142

Drug Discovery World

DECEMBER 14, 2023

With leading academic institutions and significant recent investment, Glasgow is shaping up to be an important centre for drug discovery and development in the UK. Discoveries in these areas will identify new treatments which will become the cancer drugs of the future.” DDW’s Diana Spencer explores the city’s unique ecosystem.

Drugs 75

Drugs Life Science Research Scientist 75

Pharmaceutical Technology

JUNE 8, 2023

Last month, Arexvy received approval from the US Food and Drug Administration (FDA ) for the same indication. Arexvy contains a combination of recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3) and GSK’s AS01E adjuvant.

Vaccination 147

Vaccination Vaccine Marketing Manufacturing 147

Drug Discovery World

FEBRUARY 1, 2023

Michael Sassano , CEO at SOMAÍ Pharmaceuticals looks at what’s needed throughout Europe to help increase access to medicinal cannabis and the current state of pharmaceutical research in this area. The use of medicinal cannabis across much of the world is still in its infancy.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

XTalks

JANUARY 24, 2022

Gilead Sciences has been seizing counterfeit versions of its HIV drugs Biktarvy and Descovy since last year and is now suing distributors who have been behind selling the illicit medications. The counterfeit drugs were being sold across several states in the US over the past two years. While Biktarvy brought in $7.3

Drugs 98

Drugs Pharmacy Containment Production 98

Drug Discovery World

JANUARY 31, 2024

It is also exciting that the data from the OLE show that switching to atacicept halted the eGFR decline seen in participants initially treated with placebo,” stated Richard Lafayette, Professor of Medicine, Nephrology and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center.

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

XTalks

JANUARY 5, 2024

Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). Interestingly, the company’s blockbuster diabetes drug, Mounjaro (tirzepatide), is not available through the new digital service.

Drugs 59

Drugs Pharmacy Cosmetics Insulin 59

pharmaphorum

MAY 11, 2021

Flagship Pioneering, the VC fund run by Moderna’s co-founder Noubar Afeyan has launched a new biotech Laronde , with an ambitious plan to create a new class of drugs based on Endless RNA. Called eRNA for short, this class of medicines is programmable and can continuously express therapeutic proteins inside the body.

RNA 98

RNA Drugs Protein Immune Response 98

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.

Vaccination 279

Vaccination Vaccine Manufacturing Containment 279

STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. Food and Drug Administration and the U.S. Our choice today is a Mardi Gras blend. And how is your morning going? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Last Friday, the U.S.

Clinical Trials 97

Clinical Trials Clinical Trials Regulation Drugs 97

Pharmaceutical Technology

MARCH 10, 2023

In Lebanon, the battle for access to medicines rages on and is further heightened by dramatic decreases to the healthcare budget last year. Consequentially, the five-year average price trend in Lebanon for all medicines has increased to 1,123%. Additionally, Lebanon relies on foreign currency for 80% of drugs.

Marketing 130

Marketing Branding Manufacturing Medicine 130

Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

Drug Discovery World

FEBRUARY 7, 2024

Astellas has submitted a supplemental new drug application (sNDA) in Japan for Padcev (enfortumab vedotin (genetical recombination)) with Keytruda (pembrolizumab (genetical recombination)) for the first-line treatment of advanced bladder cancer. The US Food and Drug Administration approved the combination therapy in December 2023.

Regulation 52

Regulation Containment Genetics Clinical Trials 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

Increasing drug failure rates and essential drug shortages have driven the growth of the compounding pharmacies market, which has a high growth potential, especially in emerging economies. Pharmaceutical compounding may fulfil the specific requirements of patients, unlike mass-produced medicines. Test method development.

Marketing 130

Marketing Pharmacy Containment Sales 130

Drug Discovery World

MARCH 7, 2023

DDW Editor Reece Armstrong takes a look at Qatar’s drug discovery and life sciences market, exploring how the country is utilising innovative technologies in its approach to healthcare. By 2025, it’s estimated that Qatar’s drug market will reach a compound annual growth rate (CAGR) of 3.9%

Biobanking 52

Biobanking Drugs Genome Genomics 52

STAT News

SEPTEMBER 29, 2022

The Food and Drug Administration wants to update its rules for which foods can be branded “healthy.” ” The proposed label rule aims, in part, to address a question as old as medicine: What does it mean for a food to be healthy? Read the rest…

Containment 105

Containment Branding Medicine Production 105

Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. It was previously approved in the US to treat PI in adults.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Containment 130

XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication. Elrexfio is Pfizer’s first approved multiple myeloma drug.

FDA Approval 98

FDA Approval Drugs Antibody Trials 98