News

The cabinet was set to decide on expanding the production-linked incentive (PLI) schemes in sectors like textiles, food processing, and pharmaceuticals to include more products. […]

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

Mankind Pharma announced a ₹13,630 crore acquisition of Bharat Serums and Vaccines (BSV) to be funded through internal accruals and a mix of debt and […]

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

Finished Pharmaceuticals/Unapproved New Drug

In a candid interview at the DIA conference, James Bellamy, leader of the Solutions Consulting team at Qinecsa, shared his insights into the evolving landscape […]

This week PharmaShots’ news was all about the updates on Clinical Trials, Pharma, Biotech, COVID-19, Regulatory & MedTech. Check out our full report below:                […]

The EMA’s human medicines committee has recommended against approval of Eisai and Biogen’s Alzheimer’s disease therapy Leqembi, after regulators in the US, China and Japan […]

Chiral switching, the practice of developing a single enantiomer from a previously approved racemic drug, has been a significant strategy […] Source

At this workshop, we will convene experts to share insights on product-specific guidance (PSG) development, research initiatives, bioequivalence and quality considerations, as well as case […]

Shots: The CHMP has granted positive opinion to Keytruda + Padcev as a 1L treatment of unresectable or metastatic urothelial carcinoma adults, based on first […]

Shots: Calliditas reported topline results from P-IIb (TRANSFORM) study assessing the efficacy of setanaxib 800mg AM + 400mg PM (1200 mg arm) & 800mg BID […]

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company’s clinical R&D capabilities.

Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.

This week’s round-up of new financings in the biotech world is headed by a big round for Third Arc, a specialist in T-cell engager antibodies, […]

Shots: The CHMP has granted positive opinion to Anzupgo cream (topical pan-JAK inhibitor) for treating moderate to severe chronic hand eczema (CHE), inadequately managed by […]

Discover the groundbreaking work of Cure51, co-founded by Nicolas Wolikow and Simon Istolainen, revolutionizing cancer treatment through advanced AI and biotechnology.

Cipla’s North American business achieved a record $250 million revenue in Q1 FY25, a 13% year-on-year growth. The company’s branded prescription business in India grew […]

In a letter to the new UK Prime Minister Keir Starmer, leading figures in industry and academia have called for a plan to turn the […]

Shots: The EC approved Skyrizi (induction dose: 1,200mg, IV, wks.0, 4 & 8; maintenance dose: 180mg/360mg, SC, first at wk.12 then Q8W) for moderate to […]

There will soon be two gene therapies available for patients with haemophilia B in the EU after the European Commission approved Pfizer’s fidanacogene elaparvovec under […]

submitted by /u/pharma_pti-lda [link] [comments]

The approval of donanemab marks a significant breakthrough in Alzheimer’s treatment, promising transformative changes in patient care and research.

Vaccination with GSK’s recombinant shingles vaccine Shingrix could delay the onset of dementia, according to researchers in the UK.A study published in Nature Medicine suggests […]

Statistics show that at least 129 million people in the United States have a chronic illness. To effectively deal with chronic illnesses, one needs a […]

Shots: The US FDA has granted approval to the company’s Leqselvi (8mg) tablets for treating severe alopecia areata adults Approval was supported by two P-III […]

FDA reviewers were so frustrated by AstraZeneca’s application for Imfinzi as a treatment before and after surgery for resectable non-small cell lung cancer (NSCLC) that […]

Shots: The EC has granted conditional marketing authorization to Durveqtix in severe & moderately severe hemophilia B adults not treated with factor IX inhibitors and […]

Sun Pharma announced FDA approval of Leqselvi (deuruxolitinib) 8 mg tablets for severe alopecia areata, marking a major milestone after acquiring Concert Pharmaceuticals for $576 […]

Sun Pharmaceutical Industries Ltd announced that the USFDA has approved its drug LEQSELVI (deuruxolitinib) for treating adults with severe alopecia areata. The approval is based […]

Annual Drug Patent Expirations for ABILIFY+ASIMTUFII Abilify Asimtufii is a drug marketed by Otsuka and is included in one NDA. […] Source

Annual Drug Patent Expirations for ZOKINVY Zokinvy is a drug marketed by Eiger Biopharms and is included in one NDA. […] Source

Annual Drug Patent Expirations for IBSRELA Ibsrela is a drug marketed by Ardelyx Inc and is included in one NDA. […] Source

Annual Drug Patent Expirations for XPHOZAH Xphozah is a drug marketed by Ardelyx Inc and is included in one NDA. […] Source

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2019 to 2024. Companies […] Source

An experimental drug originally developed to treat cancer may help clear HIV from infected cells in the brain, according to a new study. By targeting […]

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action […]

A new study adds to evidence which suggests treating breast cancer patients with sodium channel blockers could be a promising future treatment to prevent the […]

A gentle rumble ran under a researcher’s feet as a rocket carrying her research — live, human muscle cells grown on scaffolds fixed on tiny […]

Deployments of the new electronic health record have largely been on hold, except for the recent launch at a medical center in Illinois. Agency and […]

John Sackett will step into the role on Aug. 4.

Dataset-JSON Pilot Report and Next Steps

Developing a competitive edge in generic drug development is crucial for companies to gain a significant market share and dominate […] Source

To identify Key Starting Materials (KSMs) for Active Pharmaceutical Ingredients (APIs), pharmaceutical companies and regulatory bodies follow a systematic approach […] Source

Univercells and the University of Pennsylvania are expanding their collaboration to evaluate certain bioreactors with the aim to scale up gene therapy manufacturing.

Shots: Dedication, a go-getter attitude, and perseverance kept pushing PharmaShots to unlock new achievements now and then. Today, PharmaShots turns six Started as a news-delivering […]

The generic drug market has been significantly impacted by the COVID-19 pandemic, with both challenges and opportunities arising from the […] Source

GSK’s MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep […]

A VC investor shares how the market is recovering, which kinds of companies he’s hunting for and where he’d love to see more innovation.

The oversubscribed fundraising will enable Third Arc Bio to enter the clinic with multiple programs in 2025.

As advanced therapies drive increasing market consolidation, the US giant Agilent Technologies has acquired the Canadian contract development and manufacturing organization (CDMO) BIOVECTRA for $925 […]

Ipsen has signed yet another portfolio-expanding deal – its fifth of the year so far – claiming rights outside the US to a drug for […]

IQVIA’s One Home for Sites addresses the growing complexity in clinical research by consolidating various software applications and portals into a single, easy-to-use platform.

AstraZeneca, Roche, and Sanofi released their second-quarter results today, with a common theme – strong sales growth that caused them to raise their financial guidance […]

Back in March this year (2024) under the last UK Conservative government, plans were announced to give greater powers to pharmacy technicians, dental therapists and […]

In new guidance, NICE has cleared NHS use of Boehringer Ingelheim’s clot-busting therapy Metalyse as a treatment for acute ischaemic stroke in adults.The healthcare cost-effectiveness […]

This is the largest acquisition by Mankind Pharma, India’s 4th largest pharma company by market share. A formal announcement regarding the deal is likely by […]

Mankind Pharma is in talks to acquire Bharat Serums & Vaccines Ltd., a biopharmaceutical company with brands like Manforce Condoms and Prega News pregnancy tests. […]

Linus Health, a specialist in digital detection of dementia, has expanded its focus to include the treatment of patients with the acquisition of Together Senior […]

There has been a gene therapy on the market for people with the bleeding disorder haemophilia A since 2022, but take-up has been very slow. […]

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

Annual Drug Patent Expirations for IGALMI Igalmi is a drug marketed by Bioxcel and is included in one NDA. It […] Source

This chart shows the pharmaceutical companies with the most ointment dosed drugs. For a different perspective, see the most popular […] Source

Mayne Pharma sued India’s Sun Pharma for allegedly infringing patents on IMVEXXY, a drug for menopause-related vaginal pain. The lawsuit was filed after Sun Pharma […]

Researchers have made a significant breakthrough in developing a new gene therapy approach that restores full-length dystrophin protein, which could lead to new treatments for […]

Giroctocogene fitelparvovec is designed to allow patients to produce FVIII on their own for a time after a single infusion, an alternative to routine IV […]

Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which […]

New research has found that specific genes may be related to the trajectory of recovery for stroke survivors, providing doctors insights useful for developing targeted […]

The acquisition, expected to close in the first half of 2025, will bring the health insurer into Connecticut.

Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to […]

In the high-stakes world of pharmaceuticals, generic drugs have become the unsung heroes of healthcare accessibility. These cost-effective alternatives to […] Source

Remove the Risk raises awareness of the dangers of keeping unused opioid pain medicines in the home and provides information about safe disposal of these […]

As clinical trials continue to evolve, next-generation mobile technologies and applications are at the forefront of transforming the research landscape.

East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, […]

In the high-stakes world of pharmaceutical innovation, drafting detailed drug patent claims is a critical process that can make or […] Source

Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.

Shots:   Luvelta, an antibody-drug conjugate by Sutro Biopharma is designed to target FRα, expressed in ovarian cancer, developed and manufactured using the company’s proprietary cell-free […]

As patents expire on blockbuster biologic drugs, manufacturers are increasingly employing a controversial tactic known as “product hopping” to maintain […] Source

Shots: The P-III (AFFINE) trial assessed giroctocogene fitelparvovec (3e13vg/kg) in moderately severe to severe hemophilia A adult males (n=75); 50 subjects are from lead-in trial […]

In the second episode of the Ask the Expert video series, Susan J. Schneipp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, […]

The presumptive Democratic nominee has a long history of taking on pharma over drug prices and supporting women’s healthcare access.

[Federal Register Volume 89, (Wednesday, July 24, 2024)] [Notice] [Pages 59938-59939] Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Alleged Safety […]

Shots: The US FDA and EMA have accepted the BLA & MAA of BAT2206 for treating moderate to severe plaque PsO in adults eligible for […]

Shots: Triastek and BioNTech have entered into a research collaboration and platform technology license agreement for the development of oral RNA therapies using 3D printing […]

Biogen’s $3 billion alliance with Sage Therapeutics has suffered another setback after their drug for essential tremor failed to move the needle in a phase […]

The top three pharmacy benefit managers in the US felt the heat at a hearing of the House Oversight Committee, as lawmakers grilled executives over […]

Dear Group Members, I hope you are all doing well! My name is Laura Braun, and I am a consultant at A Piece of Pie, […]

Shots: The sNDA submission was based on development programs incl. P-IIb & P-III (ARRECTOR) assessing the safety & efficacy of Zoryve (roflumilast) foam 0.3% (QD) […]

Are you tired of long trips to the pharmacy or waiting in line for your medications? Medico LocalApp is here to change that. This easy-to-use […]

The directors of Asarina Pharma have abandoned a search for a partner for Tourette’s syndrome treatment sepranolone, saying they have no choice but to liquidate […]

Shots: The US FDA has granted 510(k) clearance to the company’s TMINI Miniature Robotic System (TMINI 1.1) for total knee arthroplasty procedures The TMINI PRO […]

MSD has reported phase 2b/3 data with its clesrovimab antibody for respiratory syncytial virus (RSV) preventions in infants, which could be a challenger to Sanofi […]

Shots: Pinetree Therapeutics has signed an exclusive agreement with AstraZeneca to develop its preclinical EGFR degrader candidate As per the agreement, AstraZeneca gets an exclusive […]

Now I know there’s a few posts about it but I would like some specific clarification please. In my research it says it is a […]

Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services […]

The Union Budget 2024, while significantly increasing health sector funding to ₹90,959 crore, failed to address the BJP’s poll promise of including senior citizens above […]

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. […] Source

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Slovakia. SPCs are used in European […] Source

The proposal, which follows a representation from a stakeholder, suggests that testing at the prescribed laboratory may be waived for cough syrups being exported to […]

Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global […]

Students and faculty from UB’s health sciences units introduced middle and high school students to a wide range of health care professions.

While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help […]

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

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Wegovy wins approvals from MHRA as drug to help reduce risk of heart problems in people who are overweight Health officials in the UK have […]

New drug that disrupts two cellular targets would make it much harder for bacteria to evolve resistance.

The drugstore retailer faces debt maturities, and the upending of some strategies introduces new uncertainties, analysts said.

Private biotech company acquisitions are on their fastest pace in years, a trend some in the industry say is driven by the abundance of mature, […]

Using one system for test execution and sample management, improving right-first-time, and allowing review by exception can deliver access to key lab data faster.

Enantiomer Switching: A Pharmaceutical Strategy to Extend Drug Patents Enantiomer switching, also known as chiral switching, is a strategy employed […] Source

Shots:   The EMA granted Positive Opinion to 3 Biologics and 4 New Chemical Entities in June 2024, leading to treatments for patients and advances in […]

CGMP/Finished Pharmaceuticals/Adulterated

CGMP/Finished Pharmaceuticals/Adulterated

CGMP/Finished Pharmaceuticals/Adulterated

FDA OCI, Operation Ancord, London, United Kingdom, U.K., Coventry, Heathrow, Langley, Berkshire,

Psychology, the scientific study of the mind and behavior, offers a rich and diverse array of career paths that can make a significant impact in […]

Shots: Merck has reported topline data from the P-IIb/III (MK-1654-004) study assessing the safety & efficacy of clesrovimab vs PBO to prevent RSV disease among […]

BARDA director Gary Disbrow explains the agency’s focus, how companies can get their “foot in the door” and why platforms are so important for preparedness.

[Federal Register Volume 89, (Tuesday, July 23, 2024)] [Proposed Rule] [Pages 59712-59714] Emergency Response Standard

ViiV Healthcare has released new data demonstrating the safety and efficacy of Apretude (cabotegravir long-acting for PrEP) during pregnancy.

As a strategic brand consultant at ramarketing, Laura combines her extensive background in clinical research with strategic leadership and creative expression.

GSK has fired a shot across the bows of Gilead Sciences’ HIV juggernaut Biktarvy, with new data showing its rival therapy Dovato is as effective […]

Shots: Aligos Therapeutics has signed a clinical trial collaboration agreement with Xiamen Amoytop Biotech per which Amoytop will fund and conduct P-Ib study of ALG-000184 […]

The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.

Shots: The USPTO has granted patent no. US 12,037,410B2 to the company’s NEO-201 (humanized IgG1 mAb), being evaluated under P-II study across the US The […]

Former Welsh rugby union captain Alum Wyn Jones is the face of a new awareness campaign launching in the UK today to draw attention to […]

Rusan Pharma Private Limited has announced that its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practice (GMP) approval […]

The government proposes to cut custom duties on Trastuzumab Deruxtecan, Osimertinib and Durvalumab from 10 per cent to nil. Finance Minister Nirmala Sitharaman also proposed […]

Ionis has committed to a phase 3 programme for its antisense therapy for rare genetic disorder Angelman syndrome, just weeks after Biogen decided against exercising […]

Generic version of a drug already on the market, which can suppress and prevent HIV, would still yield 30% profit if the current price was […]

Shots: Cytoki Pharma reported results from the P-Itrial assessing the safety, tolerability & PK of CK-0045 (IL-22 analog) among healthy & otherwise healthy obese subjects […]

Johnson & Johnson has filed for FDA approval of its antidepressant nasal spray Spravato, hoping to make it the first standalone treatment for adults with […]

German pain medicines specialist Grünenthal has dipped another toe in the M&A waters with a $250 million agreement to buy US drugmaker Valinor Pharma.The deal […]

Donating sperm is a significant decision that assists numerous individuals and couples in fulfilling their wish to have children. Nonetheless, research on sperm banks reveals […]

Mientras los pacientes se plantean fármacos como Wegovy, Ozempic, Zepbound y Mounjaro para tratar la obesidad, los expertos afirman que las opciones no son tan […]

Annual Drug Patent Expirations for LUMAKRAS Lumakras is a drug marketed by Amgen Inc and is included in one NDA. […] Source

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

Annual Drug Patent Expirations for RUBRACA Rubraca is a drug marketed by Zr Pharma and is included in one NDA. […] Source

Annual Drug Patent Expirations for ARIKAYCE+KIT Arikayce Kit is a drug marketed by Insmed Inc and is included in one […] Source

A strong patent portfolio is at the core of branded pharmaceutical firms. Accordingly, one way to assess the relative strength […] Source

Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory […]

A new study has identified new genetic and molecular risk factors that may reveal new pathways for treating patients after they experience their first stroke. […]

London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of […]

Drug repurposing shows promise in the treatment of retinal degenerations, according to a new study. A combination treatment incorporating three existing drugs — tamsulosin, metoprolol […]

A new compound shows promise in overcoming chemotherapy resistance in triple-negative breast cancer — and could potentially be applied to fibrotic conditions like liver fibrosis […]

DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related […]

FDA ‘blind spot’ grants reproduction of drugs in shortages – creating $1bn market of unbranded weight-loss drugs An obscure federal statute is allowing US pharmacies […]

I’m a zoology masters graduate with ample experience and knowledge in cell and molecular biology looking for transition into the industry. I bagged an 1 […]

In accordance with section 505A(k)(1) of the Act (Best Pharmaceuticals for Children Act of 2007 (BPCA)) and section 505B(h)(1) of the Act Pediatric Research Equity […]

The three payers were cut out of the state’s first round of contracts divvied out in April. 

An integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, […]

Accelerating a drug’s journey through early-phase development to commercialization can be made easy with precision equipment. Precision micro-dosing and powder-in-capsule (PIC) technology can help accelerate […]

In the rapidly evolving landscape of biosimilars, intellectual property (IP) strategy is paramount. Biosimilar manufacturers face unique challenges, including navigating […] Source

Shots:  Paul A. Frohna, CMO at Endeavor BioMedicines, shed light on two lead assets of the company ENV-101 for Idiopathic Pulmonary Fibrosis and ENV-501 for […]

With great potential in cell and gene therapies, there are still plenty of barriers to getting the breakthroughs to patients.  

Valneva has been awarded funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and EU to expand access to its recently approved vaccine for chikungunya, […]

Off-the-shelf consumer wearables have shown a benefit when used to monitor the response to treatment in patients with atrial fibrillation (AF) and heart failure (HF).Researchers […]

Shots: The P-III trial assesses acute pelvic pain levels after robotic High-Intensity Focused Ultrasound (HIFU) therapy or sham treatment among deep infiltrating endometriosis patients (n=60), […]

Innovent Biologics is planning a second filing for its dual GLP-1/glucagon agonist mazdutide in China, as it tries to carve out a share of a […]

Apollo Therapeutics and the University of Oxford have embarked on a collaborative journey in drug discovery and development.

Economic Survey 2024: The domestic pharmaceutical industry in India needs skill advancement, innovation, and a robust supply chain to meet the expected segment size of […]

Scientists in the US have developed a new universal form of influenza vaccine that they say could protect against all strains of the virus – […]

Shots: The US FDA has granted BDD to the company’s ContraBand System for treating heart failure with reduced ejection fraction (HFrEF) in patients, symptomatic to […]

Shots: The P-III (DREAMS-1) study assessed mazdutide (4mg, 6mg) vs PBO to treat T2D Chinese patients (n=320) with insufficient glycemic control for 24wks. after which, […]

Sanofi has announced a “temporary halt” on the sales of Allegra Suspension and Combiflam Suspension in India, due to microbiological contamination. The precautionary recall, affecting […]

Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment

In the complex and fast-paced world of healthcare, nurses stand at the forefront of patient care. Their role extends beyond basic patient management; they are […]

Best PCD Pharma Franchise Company List in India – Have you ever wondered what it takes to be part of the booming pharmaceutical industry without […]

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

This chart shows the drugs with the most patents in Austria. Patents must be filed in each country (or, in […] Source

See how Supor Prime filters performed against two comparable products in filtering fluids with antibody concentrations of 70 g/L to 220 g/L. And be sure […]

The Organisation of Pharmaceutical Producers of India (OPPI) is requesting exemptions for patented and orphan drugs from government price controls. They argue that current regulations […]

Introduction The Patent Trial and Appeal Board (PTAB) is a crucial component of the United States Patent and Trademark Office […] Source

Responses to a column by Bret Stephens. Also: Pharmacy benefit managers; the Supreme Court; a potential second Trump term and the environment.

Health systems around the world are dealing with cancelled appointments and other disruptions to services in the wake of the global IT outage that hit […]

So it has been a long road of education for me and I must be in for a life of education. A little bit about […]

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European […] Source

PluriCDMO, Pluri’s newly launched CMDO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.

Whats the average gross salary for a key account manager (pharma industry) in Croatia? submitted by /u/Character_Age9206 [link] [comments]

The Union Budget 2024-2025, pivotal for India’s Amrit Kaal vision, aims to foster economic growth and inclusive development. The budget is expected to boost infrastructure, […]

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

Annual Drug Patent Expirations for CONTRAVE Contrave is a drug marketed by Nalpropion and is included in one NDA. It […] Source

This chart shows the pharmaceutical companies with the most pellets dosed drugs. For a different perspective, see the most popular […] Source

While the number of deals reached its lowest levels since 2014, the average deal size for the first half of 2024 was 40% higher than […]

The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of […]

Scientists have discovered how the dangerous Respiratory Syncytial Virus (RSV) defuses our immune response and, in doing so, they have pinpointed an exciting new target […]

Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquenza […]

Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquezna […]

This week PharmaShots’ news was all about the updates on Clinical Trials, Pharma, Biotech, COVID-19, Regulatory & MedTech. Check out our full report below:    […]

Shots: The EMA has validated the Type II variation application of Opdivo + Yervoy as a 1L treatment of unresectable or advanced hepatocellular carcinoma (HCC), […]

Avista, a New York-based private equity firm focused on healthcare, and Hamilton Lane, a global private markets investment management firm, have announced that funds managed […]

Merdad Parsey joined Gilead as its chief medical officer in 2019 and has helped lead the company’s expansion into oncology, with mixed success.

The pharma company is tackling the “stiff person syndrome” that afflicts Celine Dion in a phase 2 trial for its lead CAR-T candidate.

With this acquisition, AstraZeneca gets a Phase III therapeutic peptide candidate that adds to the company’s rare disease pipeline.

[Federal Register Volume 89, (Friday, July 19, 2024)] [Notice] [Pages 58769] Agency Information Collection Activities; Submission for OMB Review; Comment Request; Voluntary Protection Program Information

[Federal Register Volume 89, (Friday, July 19, 2024)] [Notice] [Pages 58768-58769] Agency Information Collection Activities; Submission for OMB Review; Comment Request; Safe + Sound Campaign

Shots: The EMA has accepted MAA of Blenrep in addition to bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) for treating r/r multiple myeloma […]

Thousands of men in the UK with advanced hormone-sensitive prostate cancer could soon be eligible for an oral therapy – Accord Healthcare’s Orgovyx – that […]

Shots: Dechra has agreed to acquire Invetx for ~$520M on a cash-free & debt-free basis to expand its mAbs portfolio for companion animals The acquisition […]

Less than two years after pulling multiple myeloma therapy Blenrep off most markets around the world, GSK has filed for approval of the drug in […]

Shots: The US FDA has approved Voquezna 10mg tablets to relieve heartburn linked to non-erosive gastroesophageal reflux disease (Non-Erosive GERD) Approval was based on the […]

As patients consider drugs like Wegovy, Ozempic, Zepbound and Mounjaro to treat obesity, experts say the choices are not so simple.

The FDA has said it will create a rare disease innovation hub to help speed the development of new treatments and build connections between developers […]

Shots: Meitheal has entered into an asset purchase agreement with Nabriva to acquire Contepo’s (fosfomycin for injection) rights, strengthening its specialty biopharmaceuticals portfolio As per […]

While the pace of biotech private rounds seems to have slowed a little of late, this week saw four big financings for Cardurion Pharma, Scorpion […]

  Best Gynae PCD Pharma Franchise Company – Pharmafranchiseeindia.com is a top B2B platform committed to connecting businesses with pinnacle-notch pharmaceutical franchise opportunities. Specializing in […]

Shots: The EMA has accepted Deciphera’s (Ono’s subsidiary) MAA of vimseltinib to treat tenosynovial giant cell tumor (TGCT) for its review across the EU plus […]

Ursula von der Leyen has been re-elected as president of the European Commission following a secret ballot in the European Parliament and, among the pledges […]

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd […] Source

Annual Drug Patent Expirations for TLANDO Tlando is a drug marketed by Verity and is included in one NDA. It […] Source

Annual Drug Patent Expirations for QLOSI Qlosi is a drug marketed by Orasis Pharms and is included in one NDA. […] Source

This chart shows the companies which have received the most New Combination exclusivities in the past five years. New Combinations […] Source

The Competition Commission of India (CCI) has approved two major acquisitions involving Arjas Steel Private Limited (ASPL) and its wholly owned subsidiary, Arjas Modern Steel […]

Scientists provide a comprehensive overview of the evolution and potential of TIL therapy. They describe its development and highlight its transformative potential.

The chief executive and a lead scientist stepped down weeks after a federal grand jury filed fraud charges against a research collaborator.

The company uses AI to recommend Medicare Advantage, Medicare supplement and prescription drug plans based on enrollees’ healthcare preferences and needs.

submitted by /u/seoochre [link] [comments]

Erik Wexler, currently the health system’s COO, will step into the CEO role on Jan. 1.

Transitioning to a new Contract Development and Manufacturing Organization (CDMO) can be a complex and challenging process. However, by following […] Source

The drug supply chain has become increasingly complex as it reaches beyond U.S. borders. Threats to the supply chain such as counterfeiting, diversion, cargo theft, […]

New Delhi: Dr Reddy’s Laboratories, a Hyderabad-based firm, and Takeda Pharmaceutical entered a non-exclusive licensing pact to market 10mg and 20mg Vonoprazan tablets, a PCAB […]

Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry â a role that is growing as cell and gene therapies gain […]