Sat.Sep 03, 2022 - Fri.Sep 09, 2022

article thumbnail

Alnylam details anticipated results from heart disease drug trial

Bio Pharma Dive

Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug.

article thumbnail

Tetra and Cellvera partner to develop oral Covid-19 treatment

Pharmaceutical Technology

Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez. Onternabez is a selective full agonist of the type 2 cannabinoid receptor (CB2R).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Why We Still Use a 140-Year-Old Method to Diagnose UTIs

AuroBlog - Aurous Healthcare Clinical Trials blog

If you’ve ever had a urinary tract infection (UTI) before, you know what a pain it can be. Not just because of the physical pains it causes, but because it can also be such a pain to go to the doctor, provide a urine sample, and wait for your results. Skip advert UTIs are extremely […].

Doctor 246
article thumbnail

The current pharma business model is unsustainable

World of DTC Marketing

Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. They relied so much on a new drug that they tried to market a product with bad science behind it.

article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

FDA advisers back Amylyx ALS drug, reversing earlier position

Bio Pharma Dive

Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.

Medicine 352
article thumbnail

AstraZeneca on the hunt for new acquisitions

Pharmaceutical Technology

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.

More Trending

article thumbnail

New York's subway now has a 'you do you' mask policy. It's getting a Bronx cheer

NPR Health - Shots

Millions of New Yorkers embraced an "all in this together" motto during the pandemic — and many are roasting the city's transit agency over updated signs explaining its newly relaxed masking policy.

145
145
article thumbnail

How a top FDA official’s words helped push a closely watched ALS drug toward approval

Bio Pharma Dive

Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review.

Medicine 342
article thumbnail

Roche to acquire biopharma firm Good Therapeutics for $250m

Pharmaceutical Technology

Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash. Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.

article thumbnail

Can Brown Noise Help Get You Quickly Into A Deep Sleep? 2 Experts Weigh in

AuroBlog - Aurous Healthcare Clinical Trials blog

The latest TikTok trend has us listening to brown noise. According to TikTok, this has multiple benefits including helping you relax and quickly fall into a deep sleep. Getting insufficient sleep, and insomnia are common. Skip advert So it’s no wonder many people are looking for ways to improve their sleep. But can brown noise […].

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

STAT+: In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

STAT News

At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.

Drugs 145
article thumbnail

Relay impresses with early study data for targeted cancer drug

Bio Pharma Dive

Updated data released ahead of the ESMO medical conference suggest Relay’s medicine could be more effective than others like it in treating a type of bile duct cancer.

Medicine 312
article thumbnail

China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

Pharmaceutical Technology

The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster. This vaccine leverages the same adenovirus vector technological platform as Convidecia, the intramuscular version. Providing a non-invasive option, Convidecia Air utilises a nebuliser to convert liquid into an aerosol for inhaling through the mouth, the company noted.

Vaccine 264
article thumbnail

Scientists Just Found a New Kind of Synapse Hiding in The Brains of Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

A previously unknown type of synapse appears to have been hiding in strange, hair-like appendages that can be found on the surfaces of neurons, new research reveals. A study in mice suggests that structures called primary cilia play a role in neuronal signaling; specifically, they act as a shortcut for transmitting signals directly into the […].

Scientist 243
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Nearly 8 million kids lost a parent or primary caregiver to the pandemic

NPR Health - Shots

A new study finds numbers far higher than previously thought. India has the greatest number of kids affected. The U.S. has 250,000 kids in this category but lags behind in aid for bereaved families.

145
145
article thumbnail

Drugging RNA with pills: small molecules for a big frontier

Bio Pharma Dive

A handful of startups have formed in recent years with plans to target RNA with small molecules. Many have caught the attention of big drugmakers.

RNA 306
article thumbnail

Bayer agrees to pay $40m to resolve claims on three drugs

Pharmaceutical Technology

Bayer has agreed to make a payment of $40m for settling claims over the alleged violations of the False Claims Act linked to three drugs, Trasylol, Avelox and Baycol, the US Department of Justice said in a press statement. The settlement comes after a former Bayer employee, Laurie Simpson, filed two 'whistleblower' lawsuits against the company. These litigations were filed under the qui tam or whistleblower provisions of the False Claims Act, which facilitate private citizens to file lawsuits ag

Drugs 263
article thumbnail

There’s An Easier Way to Take Insulin, But It Hasn’t Been Tested on People Yet

AuroBlog - Aurous Healthcare Clinical Trials blog

The most effective way for people with diabetes to deliver insulin is also incredibly intrusive. Millions around the world must inject the crucial hormone underneath their skin several times a day to keep their glucose levels in balance. Skip advert For years, scientists have looked for an easier, cheaper, more convenient, and less wasteful alternative […].

Insulin 240
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

article thumbnail

The crisis in Jackson shows how climate change is threatening water supplies

NPR Health - Shots

Historic flooding and record droughts are stressing water systems across the country, and experts warn that with climate change intensifying the crisis in Jackson, Miss., may be just the beginning.

145
145
article thumbnail

Roche to pay $250M for Good Therapeutics and its targeted drug technology

Bio Pharma Dive

The team behind the Seattle-based startup will launch a new company, Bonum Therapeutics, after the sale to Roche is completed.

Sales 303
article thumbnail

India grants approval for Bharat Biotech’s intranasal Covid-19 vaccine

Pharmaceutical Technology

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals.

Vaccine 263
article thumbnail

Maharashtra FDA sets timelines for various regulatory approvals

AuroBlog - Aurous Healthcare Clinical Trials blog

The Maharashtra Food and Drugs Administration (FDA) has set timelines for various regulatory approvals with an aim to make approval process transparent and facilitate ease of doing business. On August 22, 2022, FDA came out with a circular prescribing timeline for various applications. As per the circular, the prescribed timeline for drug manufacturers’ plant layout […].

article thumbnail

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

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

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Pfizer isn’t sharing Covid vaccines with researchers for next-gen studies

STAT News

WASHINGTON — Researchers studying next-generation vaccines to fight an evolving Covid-19 threat are running into problems getting existing vaccines to use in their research. Because Pfizer and Moderna hold the patents for the current vaccines, researchers would likely have to get the companies’ permission to use them for research into products like nasal or pan-coronavirus vaccines.

Vaccine 145
article thumbnail

After safety setbacks, job cuts, Imara sells its top drug to a startup

Bio Pharma Dive

The biotech, which has lost nearly all of its value since going public in 2020, reached a deal to sell a drug it tested in sickle cell disease to Cardurion Pharmaceuticals, a richly funded startup focused on cardiovascular research.

Drugs 299
article thumbnail

US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin. This approach aids the therapy to be activated mainly in the tumour, sparing healthy tissue from exposure.

Drugs 246
article thumbnail

NACO resumes one-month dispensation of HIV medicines nationwide

AuroBlog - Aurous Healthcare Clinical Trials blog

The National AIDS Control Organization (NACO) has resumed one-month dispensation of HIV medicines nationwide following intervention by the Union ministry of health and family welfare. A group of HIV-positive people led by Delhi Network of Positive People staged a 40 days dharna in Delhi protesting shortage of antiretroviral drugs at NACO centres pan India.

Medicine 176
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Avoiding the tap water in Jackson, Miss., has been a way of life for decades

NPR Health - Shots

Residents accuse the largely white state government of neglecting the needs of a city that's 82% Black. White flight in the 1970s devastated the tax base, posing a major challenge to any solution.

145
145
article thumbnail

Regeneron answers rivals with data for new version of top-selling eye drug

Bio Pharma Dive

A high-dose form of Eylea, administered less frequently, matched the original in late-stage testing, an important step in the company’s plan to defend its bestseller against competition.

Drugs 298
article thumbnail

Gatehouse Bio and AstraZeneca to develop RNA therapeutics for heart failure

Pharmaceutical Technology

US-based biotech company Gatehouse Bio is extending its collaboration with AstraZeneca for developing RNA therapeutics to treat heart failure with preserved ejection fraction (HFpEF). Initially, the companies partnered to identify new targets for respiratory and cardiovascular diseases using Gatehouse Bio’s artificial intelligence (AI)-powered platform in December 2019.

RNA 246
article thumbnail

New Drugs Bill should ensure obligation from buyers to purchase only certified medical devices: AiMeD

AuroBlog - Aurous Healthcare Clinical Trials blog

The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].

Cosmetics 164
article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.