2019 - Drug Discovery Digest

FDA Prescription Drug User Fee Rates: Fiscal Year 2019

thought leadership

MAY 29, 2025

On Wednesday, August 1 st , FDA released a notice with updated prescription drug user fee rates for fiscal year 2019.

FDA

FDA Drugs

Genetic tracing at the Huanan Seafood market further supports COVID animal origins

Science Daily: Pharmacology News

SEPTEMBER 19, 2024

A new study provides a list of the wildlife species present at the market from which SARS-CoV-2, the virus responsible for the COVID-19 pandemic, most likely arose in late 2019. The study is based on a new analysis of metatranscriptomic data released by the Chinese Center for Disease Control and Prevention (CDC).

Marketing

Marketing Virus Disease

A trial HIV vaccine triggered elusive and essential antibodies in humans

Science Daily: Pharmacology News

MAY 17, 2024

An HIV vaccine candidate triggered low levels of an elusive type of broadly neutralizing HIV antibodies among a small group of people enrolled in a 2019 clinical trial.

Vaccine

Vaccine Trials Clinical Trials

Flagship-backed Generate raises $273M as its first drugs move to the clinic

BioPharma Drive: Drug Pricing

SEPTEMBER 14, 2023

Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.

Drugs

Pfizer to pull sickle cell drug from market, shut down trials

BioPharma Drive: Drug Pricing

SEPTEMBER 26, 2024

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.

Trials

Trials Marketing Drugs

Why petting your cat leads to static electricity

Science Daily: Pharmacology News

SEPTEMBER 18, 2024

In 2019, researchers discovered nanosized surface deformations at play. Static electricity was first observed in 600 B.C., but researchers have struggled to explain how rubbing causes it. The same researchers now say different electrical charges build up on the front and back parts of a sliding object, creating a current.

Research

Astronomers see a massive black hole awaken in real time

Science Daily: Pharmacology News

JUNE 18, 2024

In late 2019 the previously unremarkable galaxy SDSS1335+0728 suddenly started shining brighter than ever before. To understand why, astronomers have used data from several space and ground-based observatories, including the European Southern Observatory's Very Large Telescope (ESO's VLT), to track how the galaxy's brightness has varied.

Forest carbon storage has declined across much of the Western U.S., likely due to drought and fire

Science Daily: Pharmacology News

JULY 11, 2024

The paper analyzed trends in carbon storage across the American West from 2005 to 2019. But a new study confirms widespread doubts about the potential for most forests in the Western US to help curb climate change.

More Americans are using psilocybin -- especially those with mental health conditions, study shows

Science Daily: Pharmacology News

APRIL 21, 2025

Use of psilocybin, the hallucinogenic chemical found in what is known as 'magic mushrooms,' has increased significantly nationwide since 2019, according to a new study.

Rates of Anxiety, Depression Rising Among Americans, Especially the Young

Drugs.com

NOVEMBER 7, 2024

THURSDAY, Nov. 7, 2024 -- Rates of anxiety and depression among U.S. adults, especially younger folks, continues to rise, the latest federal data shows.Nearly 1 in every 5 (18.2%) adults reported anxiety issues in 2022, up from 15.6%

Americans Can Expect to Spend Half Their Lives Taking a Prescription Drug

Drugs.com

OCTOBER 18, 2023

For males born in 2019, it’s about 48% of their lives. TUESDAY, Oct. 17, 2023 -- Americans born in recent years can likely count on taking prescription drugs for about half their life, according to new research. For women, it’s 60% of.

Drugs

Drugs Research

Melting of Alaskan glaciers accelerating faster than previously thought

Science Daily: Pharmacology News

JULY 2, 2024

In particular, they found that icefield-wide, rates of glacier area shrinkage were five times faster from 2015-2019 relative to 1948-1979. The team looked at records going back to 1770 and identified three distinct periods in how icefield volume changed.

Research

Forests endure as carbon sink despite regional pressures

Science Daily: Pharmacology News

JULY 17, 2024

billion metric tons of carbon per year, which is nearly half of the carbon dioxide emissions from burning fossil fuels between 1990 and 2019. The study, based on long-term ground measurements combined with remote sensing data, found that forests take up an average of 3.5

Flavored Vapes Behind Big Surge in U.S. E-Cigarette Sales

Drugs.com

NOVEMBER 22, 2024

22, 2024 — E-cigarettes flew off store shelves between 2019 and 2023, and 80% were in youth-friendly flavors like fruit, candy, mint and menthol.In FRIDAY, Nov. all, e-cigarette sales rose 47% over the period, according to a new report from the CDC.

Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019

ProRelix Research

JUNE 6, 2023

However, […] The post Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019 appeared first on ProRelix Research. Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases.

Clinical Trials

Clinical Trials Trials Drugs Disease

Infertility Is Rising Among Young Married Women

Drugs.com

APRIL 24, 2024

WEDNESDAY, April 24, 2024 -- The percentage of married American women under the age of 50 who are infertile rose between 2011 and 2019, new government statistics show.Data from the National Survey of Family Growth show that "the percentage of.

Government

Bayer reports positive early data for Parkinson’s cell therapy

BioPharma Drive: Drug Pricing

AUGUST 28, 2023

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.

Therapies

Therapies Trials Treatment Disease

U.S. Gender-Affirming Surgeries Nearly Tripled in 3 Years

Drugs.com

AUGUST 23, 2023

23, 2023 -- The number of Americans undergoing gender-affirming surgery is on the rise, new research reveals, almost tripling between 2016 and 2019 alone. WEDNESDAY, Aug. During that period, more than 48,000 patients -- about half of them between 19.

Research

Drug Discovery Today publishes editorial on new approaches to the discovery of novel agents against 2019-nCoV (COVID - 19)

Drug Discovery Today

MARCH 18, 2020

Drug Discovery Today has today published a pre print of an editorial by Yongtao Duan, Hai-Liang Zhu and Chongchen Zhou of Henan Provincial Key Laboratory of Children’s Genetics and Metabolic Diseases, Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou, 450018, China

Laboratories

Laboratories Hospitals Drugs Disease

Vaping Rates Fall Among Teens, But Still Too High

Drugs.com

MAY 14, 2024

of teens who vaped in 2019, a new report finds.However, the 5% vaping rate. TUESDAY, May 14, 2024 -- Vaping rates among U.S. kids in grades 9 through 12 fell to 5% in 2021, the latest year for which data is available. That's down from a peak of 7.2%

Astrophysicists capture astonishing images of gamma-ray flare from supermassive black hole M87

Science Daily: Pharmacology News

DECEMBER 13, 2024

The galaxy M87, located in the Virgo constellation, provided the first-ever photo of a black hole in 2019, when the Event Horizon Telescope captured an image of the supermassive black hole at the galaxy's center.

International

International Research

Prime Editing: Adding Precision and Flexibility to CRISPR Editing

addgene Blog

DECEMBER 12, 2024

But prime editing, a CRISPR technique developed in David Lius lab in 2019, has added considerably more precision and flexibility to the CRISPR editing world. Plus, it can combine different types of edits with one another.

DNA

Gilead’s CMO to depart next year

BioPharma Drive: Drug Pricing

JULY 17, 2024

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

Tripling in proportion of smokers’ duty free tobacco purchases in England since 2019

SCIENMAG: Medicine & Health

JULY 18, 2023

The proportion of smokers’ duty free tobacco purchases in England has tripled since 2019, rising from just over 5% to just over 16%, but there’s been no reported change in black market purchases, reveals a time-trends analysis published online in the journal Tobacco Control.

Marketing

Cancers, Especially Gastro Tumors, Are Rising Among Americans Under 50

Drugs.com

AUGUST 16, 2023

Breast cancer accounted for the most cases in adults under 50 between 2010 and 2019, but. WEDNESDAY, Aug. 16, 2023 -- Breast, colon and pancreatic cancer rates are increasing at concerning rates among America's young adults, a new study finds.

Jazz drug for tremor fails study; Radiopharma drug developer ITM swaps CEOs

BioPharma Drive: Drug Pricing

JUNE 21, 2024

A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study. Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead.

Drug Development

Drug Development Licensing Licensing Drugs

Portugal Opened Its First Safe Consumption Site In 2019

Common Sense for Drug Policy Blog

DECEMBER 17, 2023

Portugal Opened Its First Safe Consumption Site In 2019 "Drug consumption rooms (DCR) are in place for more than three decades in Europe and have been proven to be effective as a public health response. In Portugal, despite being legal since 2001, the first DCR only came into reality in 2019 by the initiative of the City Council of Lisbon."

Drugs

Design and Evaluation of PROTACs Targeting Acyl Protein Thioesterase 1

Covalent Modifiers

JANUARY 10, 2024

Bernardes Nat Commun 10 , 5811 (2019). Carvalho, Bárbara B. Sousa, Daniel Zaidman, Hannah Kiely-Collins, Prof. Gonçalo J. link] PROTAC linker design remains mostly an empirical task. We employed the PRosettaC computational software in the design of sulfonyl-fluoride-based PROTACs targeting acyl protein thioesterase 1 (APT1).

Greenhouse gas emissions at 'an all-time high' -- and it is causing an unprecedented rate of global warming, say scientists

Science Daily: Pharmacology News

JUNE 8, 2023

C between 2010 and 2019. Human-induced warming, largely caused by the burning of fossil fuels, reached an average of 1.14°C C for the most recent decade (2013 to 2022) above pre-industrial levels. This is up from 1.07°C Human-induced warming is now increasing at a pace of over 0.2°C C per decade.

Mogrify wins Innovation Award and Dr. Jane Osbourn, OBE receives Lifetime Achievement Award at Scrip Awards 2019

Drug Discovery Today

DECEMBER 6, 2019

Mogrify platform recognized as having potential to transform future development of new medicines at prestigious awards ceremony. Mogrify Chair receives Lifetime Achievement Award for contributions to biologics discovery and development

Biotech IPOs bounced back in first quarter, but backlog remains

BioPharma Drive: Drug Pricing

APRIL 12, 2024

Proceeds from biotech IPOs during the first three months of 2024 matched levels seen in the first quarters of 2019 and 2020, BioPharma Dive data shows.

Landscape of In Silico Tools for Modeling Covalent Modification of Proteins: A Review on Computational Covalent Drug Discovery

Covalent Modifiers

FEBRUARY 6, 2024

However, there has been a resurgence in covalent drug design following the success of several covalent drugs such as boceprevir (2011), ibrutinib (2013), neratinib (2017), dacomitinib (2018), zanubrutinib (2019), and many others.

Drugs

Drugs Research

Merck says drug acquired in $1B buyout scores in large kidney cancer study

BioPharma Drive: Drug Pricing

AUGUST 18, 2023

The treatment, which Merck picked up through a 2019 acquisition of Peloton Therapeutics, helped delay disease progression in patients with advanced renal cell carcinoma.

Treatment

Treatment Disease Drugs

What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. What does it mean for FDA staff?

Government

Government Compliance FDA Licensing

Judge orders J&J to pay Auris investors more than $1B for merger violations

BioPharma Drive: Drug Pricing

SEPTEMBER 6, 2024

J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.

CDMO Selection: The Ultimate Checklist

Drug Patent Watch

DECEMBER 11, 2024

2019, March 6). Effective communication, cultural fit, and a comprehensive checklist are essential tools in this evaluation process, enabling pharmaceutical companies to make informed decisions and minimize risks. References Ajinomoto Bio-Pharma Services. Preparing For Your CDMO Selection Process. Contract Pharma. 2024, March 13).

Pharmaceutical Companies

Pharmaceutical Companies Compliance Pharmaceuticals Drug Development

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Drug Patent Watch

DECEMBER 10, 2024

2019, March 14). Accelerate time to market with integrated CRO/CDMO services. Retrieved from [link] Pfizer CentreOne. Three Good Reasons Why an Integrated CDMO Model Offers the Best Route to Success. Retrieved from [link] Pharmoutsourcing. Integrated CDMO and CRO Services Creates Innovation in Early-Stage Drug Development.

Drug Development

Drug Development Compliance Pharmaceutical Companies Drugs

Elacestrant

New Drug Approvals

MAY 9, 2025

1] [4] It is taken by mouth. [1] 1] [4] Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors , which are the biological targets of endogenous estrogens like estradiol. [1] 2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3]

FDA

FDA Pharmacokinetics Therapies Treatment

Talk title coming soon

Broad Institute

JUNE 4, 2025

Talk title coming soon By Nadya Karpova June 4, 2025 Talk title coming soon Lorin Crawford Microsoft Research New England (MSR) Add to calendar Talks Search - Any - Fall 2025 Spring 2025 Fall 2024 Spring 2024 Fall 2023 Spring 2023 Fall 2022 Spring 2022 Fall 2021 Spring 2021 Fall 2020 Spring 2020 Fall 2019 Spring 2019 Fall 2018 Spring 2018 Fall 2017 (..)

Research

MediSieve Founder Honoured as MIT Technology Review’s Innovator Under 35

Drug Discovery Today

DECEMBER 18, 2019

Dr George Frodsham, CEO and founder of innovative MedTech company, MediSieve, has been selected as one of MIT Technology Review’s Innovators Under 35 Europe 2019.

EIT Health receives global recognition of impact and performance for its Accelerator programme

Drug Discovery Today

NOVEMBER 19, 2019

Results from the UBI Global World Benchmark Study 2019 denoting rankings of the best accelerators and incubators have been announced at the World Incubation Summit in Doha, Qatar.

Prime editing efficiently corrects cystic fibrosis mutation in human lung cells

Broad Institute

JULY 10, 2024

A three-drug cocktail known as Trikafta has greatly improved patient quality of life since its development in 2019, but can cause cataracts and liver damage and must be taken daily at a cost of about $300,000 per year.

Engineering

Engineering Packaging DNA Treatment

RB confirms £200m UK investment commitment including new Science & Innovation Centre

Drug Discovery Today

DECEMBER 2, 2019

Hull, UK, 3rd December 2019 - RB plc, the leading global consumer health, hygiene and home company, today opens its state-of-the-art Science and Innovation Centre (“S&I Centre”) in Hull.

Science

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

APRIL 8, 2025

Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. Processing voluntary ANDA withdrawals under 21 C.F.R. 314.150(c). Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act.

FDA

FDA Drugs Production Drug Development

FDA Prescription Drug User Fee Rates: Fiscal Year 2019

Genetic tracing at the Huanan Seafood market further supports COVID animal origins

Trending Sources

A trial HIV vaccine triggered elusive and essential antibodies in humans

Flagship-backed Generate raises $273M as its first drugs move to the clinic

Pfizer to pull sickle cell drug from market, shut down trials

Why petting your cat leads to static electricity

Astronomers see a massive black hole awaken in real time

Forest carbon storage has declined across much of the Western U.S., likely due to drought and fire

More Americans are using psilocybin -- especially those with mental health conditions, study shows

Rates of Anxiety, Depression Rising Among Americans, Especially the Young

Americans Can Expect to Spend Half Their Lives Taking a Prescription Drug

Melting of Alaskan glaciers accelerating faster than previously thought

Forests endure as carbon sink despite regional pressures

Flavored Vapes Behind Big Surge in U.S. E-Cigarette Sales

Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019

Infertility Is Rising Among Young Married Women

Bayer reports positive early data for Parkinson’s cell therapy

U.S. Gender-Affirming Surgeries Nearly Tripled in 3 Years

Drug Discovery Today publishes editorial on new approaches to the discovery of novel agents against 2019-nCoV (COVID - 19)

Vaping Rates Fall Among Teens, But Still Too High

Astrophysicists capture astonishing images of gamma-ray flare from supermassive black hole M87

Prime Editing: Adding Precision and Flexibility to CRISPR Editing

Gilead’s CMO to depart next year

Tripling in proportion of smokers’ duty free tobacco purchases in England since 2019

Cancers, Especially Gastro Tumors, Are Rising Among Americans Under 50

Jazz drug for tremor fails study; Radiopharma drug developer ITM swaps CEOs

Portugal Opened Its First Safe Consumption Site In 2019

Design and Evaluation of PROTACs Targeting Acyl Protein Thioesterase 1

Greenhouse gas emissions at 'an all-time high' -- and it is causing an unprecedented rate of global warming, say scientists

Mogrify wins Innovation Award and Dr. Jane Osbourn, OBE receives Lifetime Achievement Award at Scrip Awards 2019

Biotech IPOs bounced back in first quarter, but backlog remains

Landscape of In Silico Tools for Modeling Covalent Modification of Proteins: A Review on Computational Covalent Drug Discovery

Merck says drug acquired in $1B buyout scores in large kidney cancer study

What to Expect When you are Expecting…a Government Shutdown

Judge orders J&J to pay Auris investors more than $1B for merger violations

CDMO Selection: The Ultimate Checklist

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Elacestrant

Talk title coming soon

MediSieve Founder Honoured as MIT Technology Review’s Innovator Under 35

EIT Health receives global recognition of impact and performance for its Accelerator programme

Prime editing efficiently corrects cystic fibrosis mutation in human lung cells

RB confirms £200m UK investment commitment including new Science & Innovation Centre

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

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