Noxopharm cancer drug secures Orphan Drug Designation from FDA

Outsourcing Pharma

The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma. Markets & Regulations

Drugs 52

Pharma losing the battle over drug prices

World of DTC Marketing

According to the KFF poll “ most adults – across partisans – don’t believe high drug prices are needed for drug companies to invest in new research instead agreeing that “even if U.S. The post Pharma losing the battle over drug prices.

Drugs 204
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Do patients care about accelerated approval drugs?

World of DTC Marketing

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. Since then, accelerated Approval has shifted focus to oncology drugs.

Drug companies know how to play the FDA drug approval process

World of DTC Marketing

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process.

Drug company profiteering

World of DTC Marketing

When drug makers like Xtandi’s manufacturer, Astellas Pharma, price gouge sick Americans, the U.S. The post Drug company profiteering. A cancer medication called Xtandi costs $189,800 per year and was developed with taxpayer dollars. The U.S.

The drug industry can’t fight change

World of DTC Marketing

While it’s true, the drug industry developed COVID vaccines; the government spent billions on research pre-pandemic and $18 billion more on trials, production, and purchase. Drug corps are reaping record profits. Drug companies should prepare for this scenario.

Bristol Myers' autoimmune drug shows potential in lupus

Bio Pharma Dive

Positive Phase 2 results could help boost company executives' arguments that the drug, called deucravacitinib and under FDA review in psoriasis, will become a top-seller

Drugs 268

New patent for Amicus Therap drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are thirty-five patents protecting this drug. This drug….

Drug pricing increases are disgraceful

World of DTC Marketing

SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Drug Prices

New patent for Serenity Pharms drug NOCTIVA

Drug Patent Watch

Annual Drug Patent Expirations for NOCTIVA Noctiva is a drug marketed by Serenity Pharms Llc and is included in one NDA. There are four patents protecting this drug. Drug patent….

New patent for Teva Branded drug AUSTEDO

Drug Patent Watch

Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.

Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline

Prescription drug prices are out of cotrol

World of DTC Marketing

This includes about one in five who report that they have not filled a prescription or took an over-the counter drug instead, and about one in ten who say they have cut pills in half or skipped a dose. Drug prices in the United States are extreme. Drug Prices

When Abortion Pills Were Banned in Brazil, Women Turned to Drug Traffickers

NY Times

Abortion Telemedicine Abortion Drugs Drugs (Pharmaceuticals) Women and Girls Brazil your-feed-healthcareWith Roe v. Wade overturned, states banning abortion are looking to prevent the distribution of abortion medication. Brazil shows the possible consequences.

Drugs 108

Drug price negotiations on the horizon

World of DTC Marketing

SUMMARY: Democratic lawmakers are weighing whether to include drug pricing measures that could extract tens of billions of dollars from the industry. We’re just not sure when,” said one drug industry lobbying source. The drug industry has had a large target on its back for a long time.

Novartis to invest $250M in tropical disease drug research

Bio Pharma Dive

The bulk of the investment will go toward advancing development of three antimalarial drug candidates meant to combat resistance to artemisinin, a common treatment

New patent for Abbvie Inc drug ORILISSA

Drug Patent Watch

Annual Drug Patent Expirations for ORILISSA Orilissa is a drug marketed by Abbvie Inc and is included in one NDA. The post New patent for Abbvie Inc drug ORILISSA appeared first on DrugPatentWatch - Make Better Decisions.

New patent for Ibsa Inst drug LICART

Drug Patent Watch

Annual Drug Patent Expirations for LICART Licart is a drug marketed by Ibsa Inst Bio and is included in one NDA. The post New patent for Ibsa Inst drug LICART appeared first on DrugPatentWatch - Make Better Decisions.

New cancer drug clinical trials struggling

World of DTC Marketing

This translates to longer development times for cancer drugs which means that cancer patients could suffer. It’s essential that drug companies get creative and find new ways to reach patients when incomes to cancer drug screening and clinical trials.

New patent expiration for NOVO drug SAXENDA

Drug Patent Watch

Annual Drug Patent Expirations for SAXENDA Saxenda is a drug marketed by Novo and is included in one NDA. The post New patent expiration for NOVO drug SAXENDA appeared first on DrugPatentWatch - Make Better Decisions.

New patent for Jazz Pharms drug XYREM

Drug Patent Watch

Annual Drug Patent Expirations for XYREM Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. The post New patent for Jazz Pharms drug XYREM appeared first on DrugPatentWatch - Make Better Decisions.

Clinical trial DTC? It may not be right for your drug candidate

World of DTC Marketing

The FDA approved 309 new drugs between 2011 and 2018, 38 per year on average. In 2018, the FDA approved 59 new drugs – an all-time high. The industry loses an average of $40 billion per year on drug development, part of which is due to trial delays.

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Bio Pharma Dive

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily

Concert drug helps regrow hair in study, boosting shares

Bio Pharma Dive

Concert follows Pfizer and Eli Lilly in reporting positive late-stage results for drugs they're developing for the autoimmune disorder There are no treatments specifically approved for alopecia areata.

FDA approves oral version of Mitsubishi's ALS drug

Bio Pharma Dive

Called Radicava ORS, this version is taken by mouth rather than via an hourlong infusion, which may help improve the drug's convenience and use

More federal regulators investigating Biogen's Alzheimer's drug

Bio Pharma Dive

In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes

New patent for Hope Pharms drug NITHIODOTE

Drug Patent Watch

Annual Drug Patent Expirations for NITHIODOTE Nithiodote is a drug marketed by Hope Pharms and is included in one NDA. The post New patent for Hope Pharms drug NITHIODOTE appeared first on DrugPatentWatch - Make Better Decisions.

Cancer drug shows potential as treatment for muscular dystrophy

Scienmag

Researchers at the University of British Columbia’s School of Biomedical Engineering have discovered that an existing cancer drug could have potential as a treatment for muscular dystrophy. Latest News cancer Drug dystrophy Muscular potential shows treatment

New patent expiration for Novartis drug GLEEVEC

Drug Patent Watch

Annual Drug Patent Expirations for GLEEVEC Gleevec is a drug marketed by Novartis and is included in two NDAs. The post New patent expiration for Novartis drug GLEEVEC appeared first on DrugPatentWatch - Make Better Decisions.

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

Bio Pharma Dive

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained

NIH awards $577m to antiviral drug developers

BioPharma Reporter

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern. Drug Delivery

Upstream Bio, a richly funded startup, reveals its lead drug and research plans

Bio Pharma Dive

Backed by $200 million in funding and led by biotech veteran Samantha Truex, Upstream is developing a clinical-stage inflammatory disease drug acquired from Astellas last year

How pharma can make drug information accessible

Pharma R&D Today

Pharmaceutical drugs can work wonders for patients, whether it’s treating rare diseases or easing everyday maladies. But drugs can also be complex. Also, the longer that a drug is on the market, the more its manufacturer might learn and document about its effects.

New patent expiration for NOVO drug SAXENDA

Drug Patent Watch

Annual Drug Patent Expirations for SAXENDA Saxenda is a drug marketed by Novo and is included in one NDA. The post New patent expiration for NOVO drug SAXENDA appeared first on DrugPatentWatch - Make Better Decisions.

F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients

NY Times

The drug, made by Eli Lilly, is already used for rheumatoid arthritis, and could be followed by two more drugs from other companies. your-feed-science Alopecia Areata Eli Lilly and Company Food and Drug Administration Drugs (Pharmaceuticals) New England Journal of Medicine Hair

Um, about that diabetes drug that helped patients lose weight

World of DTC Marketing

Yet the media has led with “diabetes drug leads to major weight loss” Will doctors inform patients? The drug carries a potential risk for a type of thyroid tumor and has a boxed warning. This drug can be effective if patients follow the directions for weight loss.

Drugs 176

New patent for Ironwood Pharms drug DUZALLO

Drug Patent Watch

Annual Drug Patent Expirations for DUZALLO Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug. DUZALLO drug….

New patent for Teva Branded drug AUSTEDO

Drug Patent Watch

Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.

Repurposing cancer drug to treat neuroinflammation

Scienmag

The repurposing of FDA-approved drugs for alternative diseases is a faster way of bringing new treatments into the clinic. Researchers at Karolinska Institutet in Sweden have repurposed a cancer drug for treatment of neuroinflammatory diseases such as multiple sclerosis. A novel drug carrier was also developed to facilitate drug delivery to target myeloid cells. Latest News cancer Drug neuroinflammation repurposing treat

New patent for Teva Pharm drug AIRDUO RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for AIRDUO+RESPICLICK Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. The post New patent for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

Oncotarget | Anti-cancer drug profiling with CancerOmicsNet

Scienmag

BUFFALO, NY- May 19, 2022 – A new research paper was published in Volume 13 of Oncotarget, entitled, “CancerOmicsNet: a multi-omics network-based approach to anti-cancer drug profiling.” Cancer anticancer CancerOmicsNet Drug Oncotarget profiling

Drugs 83

Pfizer, Roivant spin out new company to advance anti-inflammatory drugs

Bio Pharma Dive

The pharma licensed rights to two drugs, one of which is in late-stage testing for a rare autoimmune condition, to a new biotech jointly owned by Roivant

New legislation is a great first step to lower drug prices

World of DTC Marketing

SUMMARY: The new, proposed, drug legislation is a first step rather than a sweeping change. It’s a collection of measures meant to bring down prices slowly and on targeted drugs, and pharma is already complaining. The post New legislation is a great first step to lower drug prices.