Articles

Documents show officials were told blood plasma harvested from US convicts was contaminated with viruses • Read more: the true story of the UK infected […]

Over the past decade, India has seen significant improvements in its clinical trial landscape, with a 15-18% growth in phase two and three trials. This […]

High temperatures this week have left people sweltering and challenged businesses that need to keep their products cool.

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

Annual Drug Patent Expirations for DROSPIRENONE Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan […]

This chart shows the drugs with the most patents in South Africa. Patents must be filed in each country (or, in some cases regional patent […]

Annual Drug Patent Expirations for OXYCONTIN Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from […]

Annual Drug Patent Expirations for XOSPATA Xospata is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. […]

Annual Drug Patent Expirations for SLYND Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. It is available from […]

The virtual care giant’s earnings were dragged by flagging growth in its BetterHelp segment, which suffered an 11% drop in paying users year over year.

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Important Addresses for Regulatory Submissions

Therapeutic Biologics Applications (BLA)

A tidal wave of questions floats the need for more upstream automation.

How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces

Readers respond to a letter which said that MDMA is not helpful in mental health care Rachel McNulty (Letters, 19 April) is right to emphasise […]

The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency […]

This week PharmaShots’ news was all about the updates on Regulatory, Clinical Trials, Pharma, Animal Health & MedTech. Check out our full report below:    […]

Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development […]

The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan.

Dr. Jeremy Levin, CEO of Ovid Therapeutics, explains how scientific advances have converged to create a new era of drug development potential.

In an extensive and enlightening chat with Prasad Rajeev, the CEO of LGM Pharma, OSP gained profound insights into the company’s trajectory within the pharmaceutical […]

Chemists at ETH Zurich have developed a new computer process that enables the generation of active pharmaceutical ingredients at speed, based on a protein’s three-dimensional […]

Chemists at ETH Zurich have developed a new computer process that enables the generation of active pharmaceutical ingredients at speed, based on a protein’s three-dimensional […]

The new method could help to prevent severe side effects caused by enantiomer drugs

The paper identifies the roles and differences between LARP4A and LARP4B in sarcoma and carcinoma cancers

Shots: Vistagen reports P-IIa study (n=10) results, PH15 (1.6µg) shown statistically significant improvement in reaction time vs PBO & caffeine (p<0.001) in sleep-deprived participants at […]

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA […]

Shots: Compass received US FDA’s FTD for CTX-009 with paclitaxel to treat metastatic or locally advanced BTC patients that have been previously treated Patients in […]

Shots: Regeneron and Mammoth signed a collaboration to develop and commercialize in vivo CRISPR-based gene editing therapies by using Regeneron’s AAV and antibody engineering and […]

Shots: Onconic’s JAQBO (zastaprazan citrate) received Korea’s MFDS approval, based on comprehensive data of P-III study from 28 sites of Korea presented at UEG in […]

[](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]

Annual Drug Patent Expirations for FOTIVDA Fotivda is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one […]

Annual Drug Patent Expirations for OGSIVEO Ogsiveo is a drug marketed by Springworks and is included in one NDA. It is available from one supplier. […]

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Luxembourg. SPCs are used in European Union and select others to […]

Webinar Date/Time: Wed, May 22, 2024 11:00 AM EDT

A multicenter study has identified a potential new treatment for acute heart failure, a leading cause of hospitalization and death.

While female KMPs in the financial services sector were all professional leaders, in pharma, they were promoters, according to data from FY23 collated for ET […]

While female KMPs in the financial services sector were all professional leaders, in pharma, they were promoters, according to data from FY23 collated for ET […]

At present there is no separate pricing framework followed for medical devices. The government has been using the same framework which was created for drugs […]

At present there is no separate pricing framework followed for medical devices. The government has been using the same framework which was created for drugs […]

Peptides, proteins, and the risks of cardiac arrythmias: a CDER study suggests that the human Thorough QT study is not needed for products comprised of […]

The majority of PMCs/PMRs are proceeding according to schedule.

The nonprofit is transferring ownership of two Caritas Clinics and shutting one down.

Machines can learn not only to make predictions, but also to handle causal relationships. An international research team shows how this could make therapies safer, […]

Researchers discovered that more than 300 liver genes are under circadian control: Circadian variations affect how much of a drug is available and how effectively […]

YouTube URL:  https://youtu.be/8YVnXlr4Kgo Video Thumbnail Image: 

Wuxi AppTec says recent allegations made by the US government that it has shared clients’ data with Beijing without consent are âmisleadingâ and âinaccurateâ.

Shots:  RNAi therapeutics are innovative medications that enable rapid identification of specific inhibitors of disease targets across a wide range of molecule classes. Several biopharma […]

A recent Deloitte report revealed that 36% of healthcare product launches fell short of achieving 80% of their sales targets within the first two years.

The Pharmacy Compounding Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to compounding drugs for human use and, as required, […]

From popular weight loss drugs to lifesaving cancer therapies, recent pharma deals show the industry is doubling down on manufacturing capacity to meet demand.

Shots: Labcorp won Invitae’s auction bid, in the sale process under US Bankruptcy Code Section 363 Following the auction, LabCorp will acquire all assets for […]

Shots: Atom Bioscience initiated patient enrolment in the US for a P-IIb/III study of ABP-671 in oral formulation to treat Chronic Gout P-IIb/III study (n=580) […]

CMTX1 is the second most common form of the rare peripheral neuropathy disease

The tool will help people find out about clinical trials for myeloma, MGUS, SMM and AL amyloidosis

Exclusive: MSF calls for transparency after its bill for a trial of TB treatment came to a fraction of the billions claimed by pharmaceutical companies […]

Last month, OSP was excited to write about One2Treat, a progressive startup specializing in digital health solutions, which has launched a forward-thinking approach aimed at […]

Facts and common misconceptions about some of America’s most widely used drugs.

Nestle India and Dr. Reddy’s form a joint venture to introduce new nutraceutical brands in India. The collaboration merges health solutions and commercial capabilities to […]

Nestle India and Dr. Reddy’s form a joint venture to introduce new nutraceutical brands in India. The collaboration merges health solutions and commercial capabilities to […]

Shots: CureVac announced initiation of P-I part of P-I/II study to evaluate influenza A (H5N1) pre-pandemic vaccine (up to 5 dose levels vs PBO) in […]

Shots: US FDA granted BTD designation to Blue Arbor’s RESTORE Neuromuscular Interface System and accepted for Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot […]

Shots: The MHRA has granted marketing authorization to Ascendis’ Yorvipath (Palopegteriparatide) for the treatment of adults with chronic hypoparathyroidism, along with ODD (10 yrs. market […]

Annual Drug Patent Expirations for AYVAKIT Ayvakit is a drug marketed by Blueprint Medicines and is included in one NDA. It is available from one […]

Annual Drug Patent Expirations for LYBALVI Lybalvi is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one […]

Annual Drug Patent Expirations for SUNLENCA Sunlenca is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from […]

[](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]

Annual Drug Patent Expirations for PROBUPHINE Probuphine is a drug marketed by Titan Pharms and is included in one NDA. There is one patent protecting […]

Annual Drug Patent Expirations for NEXLIZET Nexlizet is a drug marketed by Esperion Theraps Inc and is included in one NDA. It is available from […]

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European Union and select others to […]

People who take acid-reducing drugs may have a higher risk of migraine and other severe headache than people who do not take these medications, according […]

To improve chemotherapy dosing, engineers designed CLAUDIA, a way to continuously measure how much drug is in a patient’s system during hours-long infusion.

Pivmecillinam, which has been used in Europe for decades, will become available next year to women 18 and older.

Conditions such as diabetes, heart attack and vascular diseases commonly diagnosed in people with spinal cord injuries can be traced to abnormal post-injury neuronal activity […]

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

Developing freeze-drying processes requires patience and deep product and process understanding.

The guidance is intended to help applicants and manufacturers provide the agency with timely and informative notifications about changes in the production of certain drugs […]

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development

Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and […]

Bob Hughes (Sr. Principal Scientist, Grace) and Brian Graves (Global Business Manager, Fine Chemicals, Grace) explain how Grace’s experience as a CDMO can help customers […]

Endeavor BioMedicines has completed a third-round financing, raising an impressive $132.5 million to fund trials of its two clinical-stage drug candidates for pulmonary fibrosis and […]

Senator Bernie Sanders is pressing the drugmaker Novo Nordisk for details on its pricing of the popular diabetes and weight loss medications.

From Monday 29 April 2024, the NIPVIP Program will be expanded to allow pharmacies to claim a payment for the off-site administration of National Immunisation […]

A new computer process makes it possible to generate active pharmaceutical ingredients quickly and easily based on a protein’s three-dimensional surface. The new process could […]

Researchers have published results of a phase I clinical trial of a novel immunotherapy for high-risk sarcomas.

Researchers have published results of a phase I clinical trial of a novel immunotherapy for high-risk sarcomas.

If a patient is successfully resuscitated after a cardiac arrest and circulation resumes, they are not out of the woods yet. A number of factors […]

Biogen has given an update on the rollout of its Eisai-partnered Alzheimer’s disease therapy Leqembi alongside its first-quarter results, showing that while the drug’s take-up […]

Shots: An American investment firm, OrbiMed Advisor is a prominent name when it comes to healthcare investments. The company boasts a robust portfolio of 180 […]

PCD Pharma Franchise Price List – Pharmafranchiseeindia.com is the top B2B pharma platform connecting pharmaceutical companies and associates interested in starting their own PCD pharma […]

Roche chief executive Thomas Schinecker said today that one in five of the pharma division’s pipeline of new molecular entities (NMEs) has been culled in […]

Shots: FILSPARI received conditional marketing authorization (CMA) from European Commission for treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (Urine […]

After a successful mid-stage study, the companies aim to upend traditional wet AMD treatments with a one-time gene therapy.

In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by […]

[Federal Register Volume 89, (Wednesday, April 24, 2024)] [Notice] [Pages 31221-31223] Voluntary Protection Programs; Extension of the Office of Management and Budget’s (OMB) Approval of […]

[Federal Register Volume 89, (Wednesday, April 24, 2024)] [Notice] [Pages 31223-31224] TUV Rheinland of North America, Inc.: Grant of Expansion of Recognition

[Federal Register Volume 89, (Wednesday, April 24, 2024)] [Notice] [Pages 31220-31221] Intertek Testing Services NA, Inc.: Grant of Expansion of Recognition

Shots: Angle and AstraZeneca entered into a supply agreement to develop and validate a methodology using ANGLE’s existing Parsortix-based DNA damage response (DDR) assay to […]

Shots: Neurocrine reports results from SAVITRI, a P-II study (n=183), evaluating safety and efficacy of NBI-1065845 (AMPA) in adults with MDD who had improper response […]

Any new company wanting to make waves in applying artificial intelligence to drug discovery will need deep pockets and a top-tier science and management team […]

The progressive neurodegenerative condition is the most common form of dementia

According to WHO, CVDs are responsible for an estimated 17.9 million deaths every year

An oral therapy that can allow children and adolescents with an aggressive form of brain cancer to be treated at home rather than in hospital […]

Today (April 24), Astellas Pharma Inc. revealed that XTANDITM (enzalutamide) has received a label extension from the European Commission, marking it as the inaugural and […]

India’s pharmaceutical exports surge 9.67% to USD 27.9 billion in 2023-24, despite a 3% dip in total exports. March sees a 12.73% rise to USD […]

India’s pharmaceutical exports surge 9.67% to USD 27.9 billion in 2023-24, despite a 3% dip in total exports. March sees a 12.73% rise to USD […]

Shots: Astellas received label extension approval of Xtandi as monothx or in combo with ADT to treat unsuitable salvage-radiotherapy, adult men with high-risk BCR nmHSPC […]

Orchid Pharma, backed by Dhanuka Group, focuses on cephalosporin antibiotics. Expansion plans include a new facility, Enmetazobactam launch, and mergers for sustainable growth and reduced […]

Orchid Pharma, backed by Dhanuka Group, focuses on cephalosporin antibiotics. Expansion plans include a new facility, Enmetazobactam launch, and mergers for sustainable growth and reduced […]

A new programme announced by the FDA will work towards the use of augmented reality and virtual reality (AR/VR) to make patients’ own homes an […]

Shots: Incyte to acquire Escient Pharmaceuticals for $750 M plus Escient’s remaining net cash at closing of transaction (based on customary adjustments). Closing of acquisition […]

BeiGene has claimed a second EU approval for PD-1 inhibitor tislelizumab in non-small cell lung cancer (NSCLC), opening the door to the first launches of […]

BeiGene has claimed a second EU approval for PD-1 inhibitor tislelizumab in non-small cell lung cancer (NSCLC), opening the door to the first launches of […]

Shots: US FDA granted Fast Track designation to Medicure’s MC-1 for seizures associated with PNPO deficiency. Also received Rare Pediatric Disease Designation and ODD by […]

Algunas versiones pueden provocar dependencia. Esto es lo que sabemos sobre los riesgos.

Sanofi has chalked up another win in a clinical trial of its oral BTK inhibitor rilzabrutinib, setting up regulatory filings in its first indication – […]

[](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]

Annual Drug Patent Expirations for ADZENYS+XR-ODT Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. It is available from […]

This chart shows the pharmaceutical companies with the most lotion dosed drugs. For a different perspective, see the most popular dosage types. The companies with […]

HIPAA-covered entities will be barred from disclosing patient records on abortion, IVF or other reproductive healthcare that could be used in an investigation.

Regulations for mRNA products are evolving as the market for mRNA expands.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age […]

2023 Warning Letters – Health Fraud

Researchers describe the steps they took to manipulate DNA and proteins — essential building blocks of life — to create cells that look and act […]

2022 Warning Letters – Health Fraud

Dr Reddy’s Laboratories on Tuesday said it is voluntarily recalling from the US market six lots of medication, indicated to reduce blood phenylalanine (Phe) levels, […]

Dr Reddy’s Laboratories on Tuesday said it is voluntarily recalling from the US market six lots of medication, indicated to reduce blood phenylalanine (Phe) levels, […]

Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products […]

Ultrahuman, a force in wearable technology, has boldly planted its flag on American soil with the inauguration of UltraFactory.

Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs. […]

Shots:   Raviv Pryluk, CEO and Co-Founder of PhaseV, in a stimulating conversation with PharmaShots, sheds light on the company’s recent partnership with 9xchange Biopharma    The […]

In a remarkable development, Front Line Medical Technologies Inc., an innovator in trauma care medical devices, has announced the attainment of CE marking for its […]

Failure to Register and List

Failure to Register and List

I recently had the privilege of official travel to the European Union with our global affairs team.

In a major partnership aimed at accelerating research into Rett syndrome, a rare neurological disorder predominantly affecting girls, digital healthcare solutions company Vivalink, has joined […]

Shots: The P-III trial (LUNA 3) evaluated the safety & efficacy of rilzabrutinib (400mg, BID) vs. PBO (12–24 wks. double blinded followed by 28 wks. […]

Oncimmune Holdings plc, a prominent autoantibody profiling company catering to the pharmaceutical and biotechnology sectors, is expanding its horizons by delving into the realm of […]

Mark Wildgust, vice president of global medical affairs for J&J’s oncology division, shares strategies for making clinical trials gender- and trans-inclusive.

[Federal Register Volume 89, (Tuesday, April 23, 2024)] [Notice] [Pages 30396-30398] DEKRA Certification Inc.: Grant of Expansion of Recognition and Modification to the NRTL Program’s […]

Shots: Vertex will own exclusive license for Treefrog’s cell manufacturing technology, C-Stem As per the agreement, TreeFrog will receive $25M as upfront payment, ~$540M for […]

Novartis has posted a healthy rise in sales and profits in the first full quarter since it separated from Sandoz and proposed former Bristol Myers […]

Shots: Krystal has begun first patient dosing of KYANITE-1 (P-I) study of Inhaled KB707 monotherapy in an open label trial to treat LA/M solid tumors […]

At CPhI North America, Quotient Sciences is looking forward to reconnecting with its customers and giving them a preview of how we are looking to […]

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually

Chronic liver disease and associated cirrhosis account for one million deaths every year

BenevolentAI is embarking on another round of job losses, closing its US office, and shelving its software-as-a-service business to extend its cash reserves into the […]

Some versions can lead to dependence. Here’s what we know about the risks.

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the company’s first commercial-stage […]

Shots: GENETIKA+ enters into a multiphasic collaboration with NeuroSense for its ongoing P-II study in patients with Alzheimer’s in this Genetika will use its technology […]

Cholesterol-lowering statins are frequently prescribed for primary and secondary prevention of ischaemic vascular events. Whereas most patients tolerate statins without problems, statin-associated myopathy is well […]

Background Worldwide organisations advocate standardising the management of intravenous drugs as an essential strategy to increase safety in paediatric healthcare settings. Intravenous administration is a […]

Objectives To evaluate the use of a risk stratification tool and explore the contributing factors to variation in practice by clinical pharmacists. Methods The quantitative […]

Objective As a high-efficiency demanding department in a hospital, the outpatient pharmacy has a great need for quality improvement to provide superior medical service for […]

Objectives The objective of this study was to develop a population pharmacokinetic model of meropenem in a heterogeneous population of patients with a serious bacterial […]

Objectives To evaluate the potential association between chronic exposure to medication and death related to COVID-19. Methods This is a retrospective cross-sectional study that included […]

Objective The objective of this study was to investigate the clinical efficacy and safety of conducting therapeutic drug monitoring (TDM) of vancomycin in patients with […]

Objectives Many medication errors occur during care transitions, which are critical points for patient safety. There is strong evidence in favour of medication reconciliation as […]

Objectives The evaluation and improvement of medication management processes is an essential part of preventive medication risk management strategies in hospitals. The aim of the […]

Background As cancer survivorship improves, pressure on oncology services to provide safe, timely treatments increases. Traditional manual compounding processes are error prone, putting patients at […]

Objectives The evidence for tocilizumab in the treatment of COVID-19 is contradictory, with some clinical trials showing benefits in regard to progression to mechanical ventilation […]

Objectives 177Lu-oxodotreotide (Lutathera) is an intravenous peptide receptor radionuclide therapy to treat unresectable metastatic digestive neuroendocrine tumours. The recommended method for Lutathera administration is gravity […]

Objective To evaluate the predictive performance of population pharmacokinetic models for piperacillin (PIP) available in the software MwPharm, TDMx and ID-ODs for initial dosing selection […]

Objective Drug-induced sleepiness is a frequent cause of emergency department (ED) visits for frail patients. The aim of this study was to assess the impact […]

Objectives Due to their mechanism of action, most classical cytostatic drugs have carcinogenic, mutagenic and/or reprotoxic properties. Therefore, occupational exposure of healthcare staff to these […]

Shots: In this multi-year, multi-target collaboration, Ochre Bio’s proprietary discovery platform combines RNA synthesis, deep phenotyping, and human-organ perfusion models to accelerate the discovery of […]

Pfizer’s Emblaveo has been approved in the EU with a first-in-class indication in multidrug-resistant (MDR) infections. The drug – a combination of beta-lactam antibiotic aztreonam […]

Consumir varios medicamentos aumenta el riesgo de efectos secundarios o complicaciones graves en los pacientes. Es importante saber cuándo pedir ayuda para disminuir la lista […]

Shots: Health Canada accepted New Drug Submission (NDS) for Acadia’s Trofinetide to treat Rett Syndrome; also granted priority review P-III LAVENDER study (n=187) evaluated safety […]

This chart shows the pharmaceutical companies with the most patents in Ukraine. Patents must be filed in each country (or, in some cases regional patent […]

[](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]

Annual Drug Patent Expirations for ONZETRA+XSAIL Onzetra Xsail is a drug marketed by Currax and is included in one NDA. It is available from one […]

Annual Drug Patent Expirations for RAYOS Rayos is a drug marketed by Horizon and is included in one NDA. It is available from one supplier. […]

Annual Drug Patent Expirations for NEXLETOL Nexletol is a drug marketed by Esperion Theraps Inc and is included in one NDA. It is available from […]

SOOLANTRA (ivermectin) Galderma labs lp Patent: 7,550,440 Expiration: Apr 22, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical […]

On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with […]

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene […]

Bristol-Myers Squibb has shored up manufacturing of its CAR-T therapies, tapping into capacity at contract manufacturer Cellares that will be used to supply patients in […]

Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, notes that automation is key when it comes to effective sterile […]

One way FDA works to ensure drug manufacturers comply with Current Good Manufacturing Practice (CGMP) requirements is through inspections. Learn more about actions that can […]

Plant-derived nanoparticles have demonstrated significant anticancer effects. Researchers recently developed rice bran-derived nanoparticles (rbNPs) that efficiently suppressed cell proliferation and induced programmed cell death of […]

Scientists are developing and validating a patent-pending novel immunotherapy to be used against glioblastoma brain tumors. Glioblastomas are almost always lethal with a median survival […]

After two major acquisitions, Biosynth is coming to CPHI North America ready to tell the industry about its enhanced capabilities and connect with new and […]

Andreas Frerix, product management director for Quattroflow at PSG Biotech, discussed the advantages and new challenges SUTs present for pumping systems.

I recently had the privilege of official travel to the U.K. with our global affairs team.

Kynos Therapeutics Ltd, based in Edinburgh, UK, focuses on developing small molecule kynurenine 3-monooxygenase (KMO) inhibitors for inflammatory disorders.

Shots:  The EC approved 1 Biologic and 11 New Chemical Entities in March 2024, leading to treatments for patients and advances in the healthcare industry  […]

Pacylex Pharmaceuticals Inc. has announced the presentation of phase 1 safety and efficacy findings for small molecule drug zelenirstat for cancer treatment.

Shots: Immunovia’s Next Generation Test for Early stage (I&II) detection of PDAC showed better results (with 98% specificity and 75% sensitivity) vs IMMray Pancan-d test […]

Why the legislation could throw a wrench into the supply chain for advanced therapies and how the industry has responded.

The fast-acting medication is one of a few new approaches being tested for the crippling condition.

Why the legislation could throw a wrench into the supply chain for advanced therapies and how the industry has responded.

The fast-acting medication is one of a few new approaches being tested for the crippling condition.

Shots: Ipsen and Skyhawk Therapeutics signed worldwide collaboration to discover and develop RNA targeting small molecules for rare neurological diseases Under the collaboration, Ipsen has […]

In a significant development for the multiple myeloma community, Menarini Stemline UK today welcomed the final draft guidance from the National Institute for Health and […]

More than 1,000 people with incurable blood cancer multiple myeloma could be eligible for treatment with Menarini Stemline UK’s Nexpovio after NICE backed NHS use […]

More than 1,000 people with incurable blood cancer multiple myeloma could be eligible for treatment with Menarini Stemline UK’s Nexpovio after NICE backed NHS use […]

Shots: Cresilon signed a distribution agreement with animal health and veterinary product suppliers of US (including Covetrus, MWI Animal Health, and Patterson Veterinary Supply), to […]

The launch is part of the NIHRs £42m funding to establish 14 new HRCs across England

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into […]

The neurodegenerative condition affects more than 944,000 people in the UK

Many people in the United States are taking five or more prescription drugs. That can lead to serious complications.

Shots: Hepion has begun wind-down activities of ASCEND-NASH P-IIb study, to evaluate safety and efficacy of Rencofilstat for 12 mos. to treat non-alcoholic steatohepatitis (NASH) and advanced […]

Ipsen has expanded its R&D pipeline once again, agreeing a $1.8 billion alliance with Skyhawk Therapeutics focused on the development of RNA-targeting therapies for rare […]

Shots: This collaboration will combine Vipergen’s high-fidelity DEL screening technologies and Aurigene Pharmaceutical Services’ existing small molecule drug discovery capabilities to enhance end-to-end discovery solutions […]

CSL Vifor has said it is prepared to carry out a “comprehensive and multi-channel communication campaign” to address allegations by the EU that it disparaged […]

Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market. The company is […]

Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market. The company is […]

Shots: The Osia System of Cochlear Ltd has received FDA clearance for children aged, 5-12yrs with hearing impairments like Conductive hearing loss, Mixed hearing loss, […]

The threat of low-cost competition in the US to Astellas’ Myrbetriq for urinary incontinence has moved a step closer after a court recommended denying an […]

[](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]

Annual Drug Patent Expirations for SOOLANTRA Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from […]

Annual Drug Patent Expirations for MEGACE+ES Megace Es is a drug marketed by Endo Pharms Inc and is included in one NDA. There are five […]

This chart shows the pharmaceutical companies with the most syrup dosed drugs. For a different perspective, see the most popular dosage types. The companies with […]

With the rapid development of biotechnology and molecular medicine, the introduction of mRNA as a vaccine or therapeutic agent enables the production of almost any […]

Periodontal Disease (PD) is a severe, progressive gum infection that targets the gums, inflaming and damaging the soft tissue and supporting bone around the teeth. […]

by Aloiz Kara  Aging represents a risk factor for many health problems and diseases, which means that as we grow older, there is a high […]

The healthcare landscape is rapidly transforming, fueled by the convergence of technology and medicine. Among the myriad of innovations, the Internet of Things (IoT) stands […]

The healthcare industry is actively digitalizing and employing modern tools to enrich the grade of service. Clinics incorporate virtual waiting rooms, among other software, to […]

Exclusive: NHS cost threshold has not been raised by National Institute for Health and Care Excellence since 2004 People with motor neurone disease have spoken […]

Nuevos tratamientos en desarrollo, que incluyen píldoras de una vez a la semana e inyecciones semestrales, ayudarían a controlar el virus en poblaciones de difícil […]

Natco Pharma’s Telangana plant violated cleanliness and sterilisation standards at Kothur Village facility per USFDA. The warning letter mentioned cross-contamination, inadequate cleaning procedures, and the […]

Natco Pharma’s Telangana plant violated cleanliness and sterilisation standards at Kothur Village facility per USFDA. The warning letter mentioned cross-contamination, inadequate cleaning procedures, and the […]

Pharmaceutical equipment firms are funding NHS staff and training while promoting sales Medical device companies are paying millions of pounds to hospitals in the UK […]

[](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]