Merck acquires global rights to cancer drug from Kelun in $1.4B deal
In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.

Merck acquires global rights to cancer drug from Kelun in $1.4B deal
In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
UK biotech RQ Bio emerges with $157M COVID-19 antibody deal with Astrazeneca
An unknown U.K. biotech, RQ Biotechnology Ltd., has emerged from stealth mode with a $157 million licensing deal with Astrazeneca plc for its monoclonal antibodies, aimed at protecting vulnerable and immunosuppressed people against SARS-CoV-2.
Evotec, Sernova team up to develop functional cure for type 1 diabetes
Evotec AG and Sernova Corp. are joining forces in a bid to develop a functional cure for type 1 diabetes. The companies plan to file an IND early in 2024 for a combined cell therapy and medical device product comprising Evotec’s human beta cells, derived from the company’s induced pluripotent stem cell platform, and Sernova’s Cell Pouch delivery system, which provides transplanted cells with a vascularized, physiologically appropriate environment that enables them to secrete insulin and other hormones involved in regulating blood glucose levels.
F2G finds partner for antifungal olorofim in $480M Shionogi deal
Antifungals specialist F2G Ltd. has signed an agreement with Japanese pharma Shionogi & Co. Ltd. for development and commercialization of its treatment for invasive aspergillosis in both Asia and Europe. Under the terms of the deal, F2G is getting $100 million up front and regulatory and commercialization milestones of up to $380 million. The two partners will share clinical development costs.
Avrobio’s gene therapy prompts positive phase I/II data in cystinosis
It was a patient-reported outcome, one that could actually be seen in the mirror, that alerted researchers they might be on track in their phase I/II study of cystinosis. The patient noticed that for the first time in his life his hair had become darker, like his brother’s. It was all because the rare disease inhibiting the pigment in his body was being impacted by the treatment. “It’s a secondary issue, but I find it fascinating,” Avrobio Inc.’s CEO, Geoff Mackay, told BioWorld. “When you run trials like this, you stumble upon some fascinating results.”
Today's news in brief
BioWorld briefs for May 17, 2022.
US FDA lowers age for COVID-19 boosters to 5 years old
While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier.
Nouscom unveils Janssen deal as lead cancer vaccine cleared for trials
Off-the-shelf cancer vaccine specialist Nouscom AG has taken the wraps off a multiproject agreement with Janssen Research and Development LLC, after the lead candidate received FDA approval to enter clinical trials.
Pfizer breathes life into biopharma M&As; Jazz leads dealmaking
While biopharma mergers and acquisitions are at an all-time low, a company that stood in the front battle lines fighting the COVID-19 pandemic not only completed the top M&A so far in 2022, but it also announced plans for another mega-merger shortly thereafter.
US FDA updates drug OOS guidance
Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.”

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Analysis and data insight

Biopharma stock downturn creates buying opportunity for investors
Signs of hope at the end of March were quickly dashed in the last several weeks as BioWorld’s Biopharmaceutical Index (BBI) plunged once again, albeit not as dramatically as the Nasdaq Biotechnology Index. The BBI is down by 4.4% for the year, as of May 11, while NBI has fallen 28.5%. The Dow Jones...
At $18B so far, 2022 biopharma financings lag 2021 pace
Financings
With 47% fewer biopharma financings than last year, investors who were once enthused over the industry’s potential in combatting the deadly SARS-CoV-2 virus appear to be taking a step back. So far in 2022, the industry has raised $18 billion across 346 financings through the first week of May. By...
US approvals drop as FDA moves toward modernization
Regulatory
As the U.S. FDA transitions to another new commissioner, the number of approvals has dropped to the lowest levels in seven years and is 19% below those approved by this time last year.
As COVID numbers drop, biopharma research remains steadfast
Coronavirus
For the first time since the early weeks of the COVID-19 pandemic in 2020, global deaths caused by the disease have fallen to their lowest point, as immunity against the SARS-CoV-2 virus and its variants continues to build. Infections and deaths appear to be decelerating, an optimistic sign that...

Financings

Biotech, pharma ‘dance’ ongoing as Apollo commits as much as €1B to Sofinnova
Europe
Apollo Global Management Inc. is taking a minority equity interest in European venture capital firm Sofinnova Partners, pledging to commit of up to €1 billion (US$1.04 billion) in managed capital to the latter’s investment coffers.

Science

Multiple aging hallmarks show up as epigenetic changes
Age is the biggest risk factor for just about every common disease in high-income countries, which suggests that slowing down cellular aging would have massive effects on individual and public health. Delaying the average onset of Alzheimer’s disease by five years, for example, would roughly halve...

Across body parts, ‘parts list’ gives insights into the lives of a cell
“People often think about the genome as the blueprint of the organism, but that’s not really correct,” Steven Quake told reporters at a Science press briefing earlier this week. “The genome is more of a parts list, because every cell type uses different parts.” Quake is president of the Chan...
Inflammation is key to preventing chronic pain, study finds
Inflammatory
More than 10% of Americans suffer from chronic pain, and how to prevent acute pain from turning chronic has been a critical question in pain research. But according to a study published in the May 11, 2022, issue of Science Translational Medicine, that approach has it backwards. In several animal...

Newco news

Vigeneron carves out space in evolving AAV gene therapy landscape
Ocular
Although gene therapy is now “a clinical reality,” it still remains an early stage therapeutic modality. That’s the view of Caroline Man Xu, CEO and co-founder of Vigeneron GmbH, a German gene therapy company that has maintained a low profile while steadily staking out a promising position in gene...
‘Stable’ door opens for Nuvig as $47M series A backs homeostasis bid
Immune
Nuvig Therapeutics Inc. emerged from stealth mode with a $47 million series A round to back efforts to develop drugs that induce immune homeostasis as a way of treating autoimmune diseases without disturbing the system’s normal function.
Engimmune raises $16.7M in seed round to build better T-cell receptors
Cancer
Engimmune Therapeutics AG has raised CHF15.5 million (US$16.7 million) in a seed round, as it prepares to address efficacy and safety shortcomings that currently constrain T-cell receptor and soluble TCR cancer therapies. The Basel, Switzerland-based company’s technology brings together genome...
Former Genentech execs launch new immunotherapy biotech LTZ Therapeutics
Cancer
After raising $17 million in seed funding, immunotherapy-focused biotech company, LTZ Therapeutics Inc., is announcing plans for the fledgling company whose acronym stands for “Lift to Zenith.” CEO and co-founder Robert Li told BioWorld that the company’s three-tiered immunotherapy platform will...
Keeping it simple: Kelonia raises a $50M series A
Cancer
For Kevin Friedman, the secret to making newly emergent Kelonia Therapeutics Inc. a success is reducing complexity and keeping everything as simple as possible. The Boston-based company just raised $50 million in series A funding to further its development of genetic medicines encompassing a range...

U.S.

US FDA issues draft CMC guidance
Regulatory
In a draft guidance released May 9, the U.S. FDA described the benefit-risk principles it uses when conducting quality-related assessments of chemistry, manufacturing and controls (CMC) information submitted as part of a new drug application, biologics license application or supplement.

Europe

Second booster dose increases immunity, according to Cov-Boost data
Clinical
First results from the U.K. Cov-Boost trial, looking at responses to a fourth dose of an mRNA COVID-19 vaccine, show that antibody levels increase more than after the third dose, confirming the precautionary move to give the most vulnerable a second COVID-19 booster in advance of immune response...

Pharma calls for reform to combination therapy funding in UK
Regulatory
A lack of funding for combination therapies in the U.K. could hold back investment in the country’s biopharma sector – but there are moves afoot to find ways around the issue, pinned by industry on the way the National Institute for Health and Care Excellence (NICE) assesses the value of drugs.
Swiss biotech raises $3.4B investment in 2021
Financings
Switzerland’s biotechnology sector maintained its strong investment performance in 2021. The final tally for the year came to CHF3.33 billion (US$3.4 billion), which is almost equivalent to its record-breaking total of CHF3.4 billion for 2020.

Clinical

Summer stock: Atara shares await July review of phase II MS trial
Immune
As the six-month interim analysis of phase II data for ATA-199 in progressive forms of multiple sclerosis (MS) nears, investors in Atara Biotherapeutics Inc. – not to mention patients – are growing more intrigued by the prospect, an off-the-shelf...
BMS makes case for Otezla rival deucravacitinib with long-term psoriasis data
Dermatologic
Bristol Myers Squibb Co. has announced long-term data from its closely watched psoriasis pill, deucravacitinib, which it hopes will supplant Amgen Inc.’s blockbuster, Otezla (apremilast), as the main oral therapy for the disease.
New CEO Shea to lead Inovio’s shift to COVID-19 vaccine booster strategy
Coronavirus
Newly appointed President and CEO Jackie Shea looks to have her work cut out for her, as Inovio Pharmaceuticals Inc. decided to ditch its phase II/III COVID-19 vaccination trial in favor of pursuing a booster strategy with INO-4800. That update,...
The trouble with TIGITs: Genentech’s failure sparks worry across class
Cancer
A phase III failure for Roche Holding AG unit Genentech Inc.'s anti-TIGIT immunotherapy tiragolumab dragged down the share value of several other class entrants.
Wall Street less Leary of psychedelics as field mushrooms
Neurology/Psychiatric
Not long ago, people who touted the prospects of psychedelic drugs might have been accused of hallucinating, but in the U.S. and elsewhere the space has expanded in recent years, as mental health treatments remain “stuck where cancer was 50 years...
Oxurion shares fall 40% on phase II miss in DME
Ocular
Shares in Oxurion NV dropped 40.3% percent May 9 on news that one of its two clinical-stage assets, THR-687, failed to demonstrate efficacy in a phase II trial in diabetic macular edema (DME). The candidate, a small-molecule pan integrin receptor...

BioWorld Perspectives

U.S. politicking threatens public trust in the FDA and CDC
BioWorld
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to...
When it comes to drug quality, is a ‘C’ acceptable?
BioWorld
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the...
A decade of incentives to promote antibiotic development and still no viable route to commercial success
BioWorld
It should be motoring to profitability, but nine months after the U.S. launch of its new antibiotic, Zemdri (plazomicin), Achaogen Inc. has filed for...
BioWorld's Top 10: Biggest newsmakers and trending stories of 2018
BioWorld
In many ways, 2018 resembled the previous year in fast motion. Political turmoil accelerated on both sides of the Atlantic, with Asia swept into the fold,...
Deck the halls, or get decked out: BioWorld’s 12th annual Holiday Gift Guide
BioWorld
The holidays are (already) here again. Much as we try to push back the calendar, those Thanksgiving doorbuster, Black Friday blowout, Small Business...
Price increases - tone deaf or defiant?
BioWorld
Defying the laws of nature, many drug companies seem intent on proving that what goes up doesn’t have to come down. For them, the sky’s the limit when it...
PABNAB – A disappointing distraction at BIO, not associated with BIO
BioWorld
On what planet are the PABNAB (Party at BIO not associated with BIO) organizers living to think it was acceptable to spotlight topless dancers with company...

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