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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
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Open Source “Wikipedia” for Drug Discovery

Pharma Mirror

Open source drug discovery was proposed in the past in connection with third-world diseases like tuberculosis and malaria, but it is in the context of first-world indications where it is needed most. The post Open Source “Wikipedia” for Drug Discovery appeared first on Pharma Mirror Magazine.

Drugs 299
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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 238
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A New Dimension in New Drug Molecules Research with Nanome’s VR technology [Interview]

Pharma Mirror

While these researchers rose to the occasion by discovering drugs faster than ever before, variants continue to challenge the world in addressing COVID-19. New innovations in computer-aided drug discovery tools could dramatically accelerate the study of new variants.

Research 264
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.

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The rise of prescription drug abuse and drug diversion

Pharma Phorum

As prescription drug abuse has grown in the US and Europe, the diversion of such treatments from legitimate sources has also increased. Ben Hargreaves speaks to an expert in the area to learn how drug diversion occurs, and how it can be countered.

Drugs 105
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Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

Bio Pharma Dive

The eagerly anticipated results from a Phase 2 study in psoriasis show why the pharma paid $4 billion to buy the drug from startup Nimbus Therapeutics last year

Drugs 246
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Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

Bio Pharma Dive

The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo

Trials 308
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HHS lays out timing for drug price negotiations

Bio Pharma Dive

The agency will kick off discussions on how it will negotiate Medicare drug prices in the spring and publish a list of the first 10 drugs selected by Sept.

Drugs 297
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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.

Marketing 284
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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.

Marketing 187
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J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Its most advanced drug is already in early-stage human testing Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines.

Protein 362
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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more

Protein 360
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Pfizer to buy Seagen in $43B cancer drug deal

Bio Pharma Dive

The acquisition would give Pfizer control of a top-selling lymphoma drug and a pipeline of medicines that have made the Seattle-based company one of the sector’s most valuable biotechs

Medicine 246
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Karuna’s schizophrenia drug success draws a royalty buyer

Bio Pharma Dive

PureTech Health will sell some of its royalty interest in Karuna’s drug, known as KarXT, after its second successful late-phase trial this week

Trials 174
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A new generation of biotech leaders is emerging. Can they change how drug startups are built?

Bio Pharma Dive

Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies

Drugs 363
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New patent for Paratek Pharms drug NUZYRA

Drug Patent Watch

Annual Drug Patent Expirations for NUZYRA Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. There are ten… The post New patent for Paratek Pharms drug NUZYRA appeared first on DrugPatentWatch - Make Better Decisions.

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Are new weight loss drugs an answer or problem?

World of DTC Marketing

And the Covid-19 pandemic only underscored that obesity puts people at greater risk for infectious disease but are new weight loss drugs the answer? Novo Nordisk more than doubled its sales targets for obesity drugs to $3.7bn by 2025. As I See It Weight Loss Drugs

Marketing 209
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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.

Marketing 209
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FDA rejects Cytokinetics’ heart failure drug

Bio Pharma Dive

The biotech said the FDA was unconvinced by available study evidence and asked for data from an additional clinical trial, which the company currently does not plan to run

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Spectrum to lay off R&D staff after FDA drug rejection

Bio Pharma Dive

The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib

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Novo Nordisk follows Lilly in sharply cutting price of insulin drugs

Bio Pharma Dive

Responding to policy changes and pressure over high drug costs, the pharma is reducing the sticker price of four branded diabetes medicines by up to 75

Insulin 283
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Karuna’s schizophrenia drug succeeds in a second late-stage trial

Bio Pharma Dive

The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder

Trials 273
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Merck builds out cancer drug pipeline with Kelun-Biotech deal

Bio Pharma Dive

The pharma will pay the Chinese drugmaker $175 million for access to seven preclinical antibody-drug conjugates, deepening ties established this year

Antibody 297
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Fentanyl: a horrifyingly disruptive drug

Pharmaceutical Technology

The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American. A lethal drug that creates its own demand.

Drugs 264
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FDA approves cancer drugs from Lilly, Menarini

Bio Pharma Dive

The agency’s clearance of Jaypirca gives Lilly another win from its Loxo buyout, while Menarini Group’s bet on Radius Health’s oral SERD has now paid off with Orserdu’s OK

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Which pharmaceutical drugs have the most drug patents in Ukraine?

Drug Patent Watch

This chart shows the drugs with the most patents in Ukraine. The post Which pharmaceutical drugs have the most drug patents in Ukraine? Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…

Drugs 96
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Celanese partners with Johns Hopkins on eye drug delivery

BioPharma Reporter

The partners will collaborate on a study of sustained drug delivery to the suprachoroidal space in the eye. Drug Delivery

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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

Marketing 181
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Ventus sells its lead drug candidate to Novo Nordisk

Bio Pharma Dive

The biotechnology startup will part with its lead drug candidate, an anti-inflammatory small molecule, in Novo Nordisk’s bet on inflammasome treatments

Drugs 330
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Lilly reaches end of the road with long-studied Alzheimer’s drug

Bio Pharma Dive

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease

Scientist 303
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BMS: Delayed new drug to avoid paying billions?

World of DTC Marketing

billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec.

Marketing 216
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New patent for Vertex Pharms drug ORKAMBI

Drug Patent Watch

Annual Drug Patent Expirations for ORKAMBI Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are twenty… The post New patent for Vertex Pharms drug ORKAMBI appeared first on DrugPatentWatch - Make Better Decisions.

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Expediting IND applications with drug master files

Bio Pharma Dive

By taking advantage of pre-filed DMFs, researchers benefit from the value, time savings and reduced complexities of having someone else do the heavy lifting for key components of the final drug product

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Takeda wagers up to $6B on Nimbus’ TYK2 drug

Bio Pharma Dive

The Japanese pharma is paying $4 billion upfront, and potentially $2 billion more, for a medicine Nimbus claims can top Bristol Myers’ recently approved psoriasis drug Sotyktu

Medicine 283
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Arrowhead capitalizes on Amgen drug progress with royalty rights deal

Bio Pharma Dive

The biotech will sell its royalty interest in a heart disease drug Amgen is developing for $250 million, extending its operating runway by several quarters

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Pfizer, Roivant set up new company around inflammation drug

Bio Pharma Dive

The drug is currently in mid-stage testing as a treatment for ulcerative colitis. If it continues to advance, it could be the first approved therapy aimed at a protein known as TL1A, a target multiple other companies are pursuing

Protein 313
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New patent for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are thirteen… The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

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Pfizer advances diabetes, obesity drug hopeful into mid-stage testing

Bio Pharma Dive

The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen

Drugs 297
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Biogen licenses subcutaneous drug delivery system for neurological drugs

Outsourcing Pharma

Drug DeliveryBiogen partners with Alcyone to gain access to ThecaFlex, which is able to deliver therapies into the intrathecal space.

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Karuna, hoping to find new brain drugs, buys up a shuttering biotech’s pipeline

Bio Pharma Dive

Though Goldfinch Bio focused on kidney diseases, Karuna believes its experimental drugs may have potential treating psychiatric and neurological conditions

Drugs 289
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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.

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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.

Marketing 187