The most common types of drugs in drug development are small molecules and biologics. Small molecules have a long history in the pharmaceutical industry and remain a pillar of modern medicine. Conversely, biologics are more complex molecules derived from living organisms. In this article, we provide a brief overview of common drug types, including biologics, small…
A pandemic waiting to happen: Acute radiation syndrome and the immediate need for nuclear countermeasures
In case of nuclear war, or even a limited nuclear strike, the greatest threat to human health, besides blast and burn injuries, is from acute radiation syndrome or ARS. This ominous and little-known acronym refers to the acute illness that ensues from significant partial- or whole-body irradiation. High turnover tissues such as the skin, bone…
Lilly gets FDA review for empagliflozin in chronic kidney disease
The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD). Some 37 million people in the U.S. have CKD. Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim. The…
Genascence believes gene therapy can transform the treatment of knee osteoarthritis
Osteoarthritis (OA), a degenerative joint disease affecting the knee and other joints, affects hundreds of millions of people worldwide. Genascence (Palo Alto, California) is developing a gene therapy known as GNSC-001 for OA of the knee. A potent inhibitor of interleukin-1 (IL-1) signaling, GNSC-001 is a recombinant adeno-associated virus vector with a coding sequence for…
Activist investors pressure MindMed to accelerate clinical development, trim costs
The psychedelic therapeutics market could be worth billions of dollars in the coming years. The FDA has awarded breakthrough therapy designation to psilocybin and MDMA, potentially accelerating its approval of the currently Schedule I substances. Despite the promise, several psychedelic therapeutics companies have seen substantial drops in stock price. For instance, MindMed has seen its…
Takeda and Boehringer Ingelheim selected as top pharma employers
The Top Employers Institute has named Takeda (TSE:4502/NYSE:TAK) and privately-held Boehringer Ingelheim to its list of 15 companies to win global Top Employer certification for 2023. The Top Employers Institute rankings are based on data from its HR Best Practices Survey, which spans 20 topics, including people strategy, work environment, talent acquisition, learning, diversity and inclusion, well-being…
4 top drug discovery innovations of 2022
Late last year, the Galien Foundation highlighted several drug discovery innovations in its annual Prix Galien USA Award Winners, which specifically highlighted drugs from Regeneron and Amgen as well as a platform from Exscientia and the incubators BioLabs and LabCentral. The foundation recently hosted a webinar featuring several executives from the respective winning companies discussing their view…
Moderna’s RSV vaccine mRNA-1345 was more than 80% effective in a Phase 3 study
mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434). The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a…
25 potential blockbusters to keep an eye on in 2023
In 1986, the ulcer drug Tagamet from Smith, Kline and French (now GSK) emerged as the first blockbusters, generating more than $1 billion in annual revenue. Fast-forward to 2021, and the COVID-19 vaccine from Pfizer and BioNTech generated close to $60 billion in cumulative revenue. That same year, AbbVie’s Humira (adalimumab) eclipsed $20 billion in sales…
Why the immunotherapy startup 3T Biosciences is working with Boehringer Ingelheim
At the dawn of 2023, 3T Biosciences and Boehringer Ingelheim (BI) revealed a strategic collaboration and licensing agreement focused on the discovery and development of next-generation cancer therapies focused on high unmet patient needs. The alliance unites 3T Biosciences’ 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform and Boehringer Ingelheim‘s focus on cancer cell-directed…
CinCor stock surges after AstraZeneca announces plan to buy company for up to $1.8B
AstraZeneca (LON:AZN) announced it had reached an agreement to acquire CinCor Pharma (Nasdaq:CINC). After announcing the proposed deal, CinCor’s share price jumped 144% to $28.74. AstraZeneca has agreed to a tender offer to acquire outstanding shares of CinCor for $26 per share, or $1.3 billion. CinCor specializes in developing therapies for hypertension and chronic kidney…
Proteomics can help us realize a future of precision healthcare: Takeaways from a 2023 prediction
Clinicians are ready and eager for the future of diagnostic and prognostic models — ones that are built on proteomics. I have been feeling and hearing one key theme in 2022 – physicians are ready, even dare I say eager, to get their hands on proteomic tests and tools that better empower and equip them…
How Parallel Bio aims to turn drug development on its head
In 2021, two scientists founded Parallel Bio to harness the human body’s ability to fight disease using the immune system. The Cambridge, Massachusetts–based company is developing a platform for drug discovery and development that replicates human immune systems at population scale. The company has grand ambitions. “Nearly 95% of drugs that make it to human trials fail…
Drug Discovery & Development’s top stories of 2022
After the majority of pharmaceutical companies released their earnings reports for 2022, we released our annual Pharma 50 feature detailing how the pharma landscape has evolved. Four of the five most popular pieces of content on Drug Discovery & Development were part of the Pharma 50 feature. In the past year, Pfizer (NYSE:PFE) cemented its…
Congress passes FDA act that would do away with animal testing requirement
The U.S. House has approved the FDA Modernization Act 2.0, which would end the animal testing requirement for new drugs and biosimilars. The bill doesn’t completely ban testing on animals but enables drug developers to use alternatives when feasible. In September, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002. The new policy, known as the…
Overcoming the biotech investment paradox
As COVID wreaked havoc on our markets, biotech appeared to be an outlier, not just weathering the storm but emerging stronger than ever with record investments and valuations. Then reality struck. Assets lingered in the early stages. Commercialized products underperformed. Valuations tumbled. Now, a new normal has arrived, presenting a biotech investment paradox to small…
Otonomy plans to dissolve
The neurotology biopharma Otonomy (Nasdaq:OTIC) is planning to liquidate and dissolve its business. It plans to distributing any remaining cash to shareholders after its operations have been suspended and its pipeline assets have been sold. The company also announced that it had terminated all of its employees effective December 15. In 2017, Otonomy announced that …
The importance of computer software assurance in the life sciences industry
The primary goal of the life sciences industry is to improve access to treatment and increase positive healthcare outcomes for patients. In a constantly evolving landscape, the industry works to achieve this goal through research, development, and the manufacturing of pharmaceuticals, medical devices and biotechnological products — all of which emphasize patient safety, product quality…
The top 10 pharma M&A deals of 2022
2022 was a shaky year for M&A deals in the pharmaceutical and life sciences sector, as PwC recently surmised. That’s not surprising, given the recession fears and inflation themes common throughout the year. That said, Amgen (Nasdaq:AMGN) and Pfizer bucked the trend by spending 11-figure sums on M&A deals. Bristol Myers Squibb, Biocon Biologics and GSK…
Biden administration’s antitrust campaign a concern for pharma
Last year, the Biden administration drafted an executive order that promoted competition in the U.S. economy across several industries, including pharma and biotech. The focus on the pharma industry was not surprising, given Biden’s campaign pledge to curb drug pricing. To that end, the Biden administration has explored a variety of approaches, according to Robin Adelstein, the…
What to expect from AI-enabled drug discovery in 2023
Pharma and biotech companies are scratching the surface when deploying artificial intelligence to streamline drug discovery and development. But the AI-enabled drug discovery sector is maturing, according to Chris Gibson, co-founder and CEO of Recursion Pharmaceuticals. More AI validation is coming in 2023 Competition is helping drive the field of AI-enabled drug discovery forward. “Over the last…
The top 15 drug discovery and development predictions of 2023
Technology enabling the discovery and development of new drugs is rapidly evolving. We asked representatives from KBI Biopharma, Phylloceuticals and Provectus Algae for their predictions on the platforms and technologies that will have the biggest impact on drug discovery efforts in 2023. 1. 2023 could be ‘massive showcase’ for ML in pharma Drug developers are…
FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals
ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription…
Alvotech announces new CEO and chief operating officer
The biosimilars firm Alvotech (Nasdaq:ALVO) has announced that its CEO, Mark Levick, will retire. As of January 1, the company will install Robert Wessman, executive chairman and founder, as its top exec. Reykjavik, Iceland–based Alvotech also announced that it had retained Hafrun Fridriksdottir as its chief operating officer. Fridriksdottir was formerly the executive vice president…
Lilly completes acquisition of Akouos
Eli Lilly and Company (NYSE:LLY) announced today that it successfully completed its acquisition of Akouos (Nasdaq:AKUS). Indianpolis-based Eli Lilly’s acquisition expands its efforts in genetic medicines. Akouos offers a portfolio of potential first-in-class adeno-associated viral gene therapies. The gene therapies treat inner ear conditions, including sensorineural hearing loss. The company initially announced the acquisition in…