Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.
Shots: Takeda will lead the regulatory approval and commercialization of maralixibat in Japan & will also be responsible for the development, including conducting clinical studies in cholestatic indications The collaboration will utilize Takeda’s leadership in rare disease, gastroenterology, and hepatology to advance the product in Japan Mirum has submitted a maralixibat’s NDA to the US …
The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment with chemotherapy. Tivdak is Seagen’s third ADC; for Genmab, the drug will become its first commercialized product.
Shots: The companies collaborated to evaluate the safety, tolerability & efficacy of Verastem’s VS-6766 + Amgen’s Lumakras in the P-I/II trial for patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor & who have progressed on a KRAS G12C inhibitor. The trial is expected to start at the …
The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.
A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.
Shots: Sinovent & SinoMab to receive $12M up front, ~$549M in development, regulatory & commercial milestone along with royalties on net sales of a product The agreement will strengthen Everest’s leadership in developing novel therapies for renal disease in Greater China & Asia. The agreement also includes technology transfer of manufacturing process to Everest for …
Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help it meet growing demand for gene therapy solutions.
An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the …
Rune Labs developed software that aggregates brain data, providing insights for clinical care and clinical research. Health systems are starting to adopt the technology, and the startup has now raised $22.8 million to grow that part of the business while also expanding use of the technology in drug development.
Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.
Shots: The P-IIIb ASCEND study will evaluate the clinical outcomes & safety of the higher doses of nusinersen in 135 patients aged 5-39yrs. with SMA prior treated with Evrysdi at MRD (5mg). Patients will receive 2 loading doses of nusinersen (50mg, 2wks. apart), followed by a maintenance dose of 28mg, q4mos. in study period & …
Dice Therapeutics raised $204 million from its IPO to support development of oral drugs that could compete against biologic drugs that are injected or infused. Also debuting on the public markets were Tyra Biosciences and Procept BioRobotics.
The clinical trial failure of Theravance Biopharma’s most advanced internal program, a drug for a rare blood pressure disorder, is leading to a companywide restructuring. Going forward, the biotech will focus on developing drugs for respiratory disorders.
Vanqua Bio aims to treat rare form of Parkinson’s disease by boosting activity of an enzyme that is deficient in patients who have a particular genetic mutation. With $85 million in Series B financing, the biotech startup, which is based on Northwestern University research, aims to reach human testing within two years.
The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.
If there was an AI solution in the Life Sciences field, able to represent a real opportunity in terms of Customer Engagement and Digital Transformation, and if some of the most important players in the industry already had it, would you like to have the opportunity to listen to them? This and other trend …
Shots: Nuformix is eligible to receive an up front, development milestone along with royalties when the net sales reaching $2.76M/annum Oxilio gets an exclusive license to research, develop and commercialize NXP001 globally for oncology indications. The agreement allows Oxilio to focus on developing a unique formulation and dosage form with NXP001 to progress into the …
Walking Fish Therapeutics is developing cell therapies from B cells, a type of immune cell that produces prodigious amounts of proteins. Cancer, autoimmune disease, and regenerative medicine are among the targets of the preclinical-stage biotech, which unveiled $50 million in funding.
AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, coming months after it committed $90 million to preclinical-stage Capsida Biotherapeutics.
Shots: Regenxbio to receive $370M up front in addition to ~$1.38B as development, regulatory and commercial milestones along with royalties on net sales of RGX-314 outside the US. The transaction is expected to close at the end of 2021 Regenxbio will be responsible for the manufacturing, clinical development & commercial supply for the therapy in …
Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.
The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical trial application. Kaleido claims the filing was not required because the product is a medical food, but the regulator doesn’t buy that argument.
Biotech startup iECURE is based on work from the University of Pennsylvania scientist, who has been researching ways to use in vivo gene editing as a way to “knock in” healthy versions of a gene to treat rare liver diseases. The company, which will develop therapeutic candidates from Penn, has raised $50 million in Series …
A-Alpha Bio’s technology analyzes millions of protein-protein interactions simultaneously, a capability that speeds up drug discovery research. Biotech industry partners are already using the technology and now with $20 million in Series A funding, the startup plans to build machine-learning capabilities to crunch the data produced by all of those protein interactions.
The cash deal brings to Sanofi the Kadmon Holdings drug Rezurock, which the FDA approved in July as a treatment for chronic graft versus host disease. The French pharmaceutical giant will add Rezurock to a lineup of older products marketed globally for transplant procedures.
Shots: AM-Pharma to receive $23.6M up front, $35.4M in milestones before regulatory submission and ~$230.4M upon submission, NHI price listing & sales milestone along with royalties on sales and a drug supply fee Kyowa Kirin to get the exclusive right to develop and commercialize ilofotase alfa in Japan. Ilofotase alfa is currently being evaluated in …
Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also develop a personalized allogeneic cell therapy designed specifically for a patient’s cancer.
A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed …
Shots: Advent and GIC to acquire Sobi for ~$8B (SEK 69.4B) at $27.33/share (SEK 235) representing a premium of 34.5% to the closing price of $20.41. The offer acceptance period is expected to start on Sept 2021 and expire on Oct 21, 2021 Sobi focuses on delivering innovative therapies and services in the areas of …
Shots: Dr. Reddy’s to receive $40M up front upon the closing of the transaction, followed by ~$40M milestones on E7777’s approval in CTCL and ~$70M for additional indication approvals. Additionally, Dr. Reddy’s will receive commercial milestones and royalties Citius to get all the rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related …
The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.
A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney transplant patients. Other clinical trial failures announced ahead of the Labor Day weekend include a Forte Biosciences atopic dermatitis drug, as well a cancer therapy from Takeda Pharmaceutical.
A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicines. CEO John Quisel said Roche’s clinical data showed the small molecule’s promise addressing a rare blood disorder and now the biotech startup has $90 million to advance that drug and another one into Phase 2 testing.
Four patients dosed with an experimental Assembly Biosciences hepatitis B treatment developed high levels of liver enzymes, a sign of drug-induced liver toxicity. The biotech has decided to stop further work on that drug and focus instead on developing its other clinical-stage hepatitis B drugs.
The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency is requiring additional warnings flagging those risks. The updated warnings extend to AbbVie and Eli Lilly medicines in the same drug class.
Five months after raising $55 million to back a new technology and a promising lead cancer immunotherapy, Asher Biotherapeutics has reeled in $108 million more. CEO Craig Gibbs said investors were enticed by encouraging new data suggesting Asher Bio’s lead program is superior to a competitor’s.
Johnson & Johnson reported results from a mid-stage study in southern Africa showing just 25% efficacy for its HIV vaccine. J&J developed the HIV vaccine with the same technology used in its successful Ebola and Covid-19 vaccines.
Novartis was unsuccessful developing bimagrumab as a treatment for a rare muscle disorder, but additional tests showed encouraging results in fat reduction. Startup Versanis Bio licensed rights to the antibody and plans to use its Series A financing for clinical trials testing the drug in obese patients.
Before developing any stakeholder engagement plan, it is crucial to have a clear understanding of all the relevant individuals and groups your product or device could directly impact or interest in some way. Stakeholders within the pharmaceutical world encompass many diverse groups and include payers, government bodies, standard-setting bodies, physicians, key opinion leaders, patients, and …
Tie-ups of candy makers and nutritional product companies into a single firm called Bettera has culminated in a $1 billion acquisition by Catalent. The global contract manufacturing giant plans to leverage Bettera’s ability to produce gummies and chewables as a way to offer its customers new formulation options for nutraceutical products.
Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.
Aaron Ferguson, COO and co-founder of Vytal Challenging the status quo is never easy. Neither is being the underdog. Startups face both of these challenges when trying to break into existing industries dominated by well-established players. Differences in the size, speed, processes, and culture of a company make it challenging for all startups to compete, …
Full FDA approval of Pfizer and BioNTech’s Covid-19 vaccine was the biggest news in a busy week for coronavirus vaccines, drugs, and diagnostics. Here’s a look back at some of the major developments.
The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.
Shots: Wanchunbulin to receive $30M up front, $170M as regulatory and sales milestone & is eligible to receive $15M as equity investment at a pre-money valuation of $560M Hengrui gets exclusive rights to commercialize & co-develop plinabulin in Greater China and will be accountable for all costs associated with the commercialization of plinabulin in the …
The royalty agreement with HealthCare Royalty Partners will support ADC Therapeutics’ plans to commercialize its newly approved cancer drug and develop the next one in its pipeline. The biotech’s drug Zynlonta is the first of its type approved by the FDA as a treatment for diffuse large cell B-cell lymphoma
Eli Lilly is entering the field of protein-degrading drugs through a partnership with Lycia Therapeutics, a startup whose technology goes further than the first wave of such drugs. Lilly paid $35 million to begin the alliance, which spans up to five drugs.
As U.S. plans for Covid-19 booster shots unfold, Johnson & Johnson is angling to join the mix, reporting data that it says support a second shot of its vaccine. But the data the company points to are sparse and it’s not entirely clear they support booster shots.
Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the FDA’s nod green light for its injectable drug, Korsuva.
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.
Shots: Genevant is eligible to receive ~$303M up front and milestone along with royalties on future product sales Takeda gets exclusive rights to use Genevant’s LNP technology for the development and commercialization of specified nonviral gene therapies for up to two undisclosed rare liver diseases The collaboration follows the initial 2021 agreement in which companies …
Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the Trillium Therapeutics acquisition have safety and efficacy advantages that could make them the best in this emerging drug class.
Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.
Vigil Neuroscience led the way with a $90 million round of funding, one of four biotech companies to close Series B financing rounds in the past week. The fresh capital comes as each of the companies looks ahead to bringing their respective drugs into the clinic.
An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant pulls ahead of other companies developing injectable versions of antibody drugs for Covid-19 prevention.
Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic lateral sclerosis. Despite failing in ALS, Alexion, recently acquired by AstraZeneca, brings additional clinical-stage programs for rare diseases.
Shots: The companies collaborated to evaluate the safety and preliminary efficacy of Werewolf’s WTX-124 as monothx. or in combination with Merck’s Keytruda (anti-PD-1 therapy) in a P-I trial for patients with solid tumors The company plans to submit an IND application for WTX-124 to the US FDA in H2’22 WTX-124 is a systemically delivered, conditionally …
In announcing plans to offer Covid-19 booster shots, federal health officials cited declining vaccine efficacy shown by real-world studies. But the World Health Organization said the science is less than clear about booster shots, adding that it’s ethically wrong to give third shots when so many around the world are waiting for their first one.
GlaxoSmithKline drug Jemperli is now FDA approved for treating solid tumors throughout the body as long as they have a particular genetic signature. Expanding the drug’s approval means the drug can treat more patients who have more types of cancer, and it also gives GSK a way to grow revenue in its thin oncology portfolio.
Verily’s recent moves have signaled the company’s interest in supporting decentralized clinical trials and real-world studies. Now the life sciences subsidiary of Alphabet is bolstering its capabilities in this these areas with the acquisition of startup SignalPath.
Gritstone bio is developing Covid-19 vaccines that use self-amplifying messenger RNA, which is intended to further boost the immune response compared to mRNA alone. The company also says its vaccine candidates may be able to protect against variants of the novel coronavirus.
For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.
FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.
Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the results of two small studies that tested third shots of the mRNA Covid vaccines from Moderna and Pfizer/BioNTech.
FDA approval of a therapy that pairs drugs from Eisai and Merck allows the combination to become a first-line treatment for renal cell carcinoma. It’s the latest approval for the partners, which have been working together since 2018.
For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.
With advertisers preparing to spend up to $15 billion on influencer marketing by 2022, pharmaceutical and biotech companies are increasingly (and carefully) engaging trusted health social influencers to connect more authentically with consumers. As pharma starts to leverage a multitude of high-engagement channels like influencer marketing, online communities and virtual health services, the industry finds itself …
Shots: Takeda will lead the development of FIN-524/TAK-524 to treat UC prior to the start of its clinical program & will leverage its expertise in IBD throughout the development process Finch plans to provide ongoing technical support through the P-I trial of FIN-524/TAK-524 in the same indication. The companies will continue to advance the program …
The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma companies must ensure they are working toward a clear-cut common goal, according to panelists at HIMSS 21 Digital.
Following several legal battles and opposition from providers, CMS is proposing nixing the Most Favored Nation Model, which matches payments for Medicare Part B drugs to the lowest price paid by other wealthy countries.
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an important, controversial decision from the Federal Circuit.
The short answer is that cancer vaccines represent no silver bullet but, in combination with other immunotherapy and drug cocktails, can prove potent.
Identifying the most important & active digital experts in your space is just the first step of the engagement planning cycle. Because even within a therapy area, digital KOLs (DOLs) have very different online characteristics – those who tend to initiate online conversations, those that tend to create new content, those that tend to propagate …
Sanofi is acquiring Translate Bio, its messenger RNA R&D partner for the past three years, in a $3.2 billion deal. The pharmaceutical and vaccines giant said the acquisition will speed up development of partnered vaccine programs and spark work on new ones in areas such as cancer, immunology, and rare diseases.
An AstraZeneca lupus drug has been awarded FDA approval for treating the most common form of the autoimmune disorder. The regulatory decision gives AstraZeneca a product that can compete head-to-head with GlaxoSmithKline’s lupus drug, Benlysta.
Ipsen is shoring up its neuroscience pipeline via a deal that gives it the option to license drugs that Exicure is developing for Huntington’s disease and Angelman syndrome. The programs are based on Exicure’s proprietary technology that produces nucleic acid therapies capable of delivery deep into the brain.
Of the 20 companies that went public in the last week of July, 11 of them represent some aspect of the life sciences. The tally of newly public companies made the week the biggest for IPO activity in more than 20 years.
Icosavax’s research developing a vaccine for a virus that can lead to deadly respiratory infections in the very young and the very old has found an additional application in the pursuit of a vaccine for the novel coronavirus. The biotech’s $182 million IPO gives it the capital to move forward with clinical research on multiple …
Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational study, which is one of three post-marketing clinical programs planned to generate more data about the drug
Shots: The sNDA is based on the P-III JUPITER-06 study evaluating toripalimab + CT vs PBO + CT in 514 patients with locally advanced or metastatic ESCC The results of the study showed that toripalimab + CT significantly improved both PFS and OS for patients with advanced or metastatic ESCC, regardless of PD-L1 expression status. …
Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two weeks after the company received an FDA letter citing deficiencies in the drug application.
Eli Lilly is beginning a research alliance discovering and developing small molecules that stimulate immune responses against cancer. If drugs from the partnership reach the market, Kumquat could earn up to $2 billion in milestone payments.
Shots: Protagonist to receive ~ $900M as development & sales milestones along with $80M already received under the original agreement with royalty rates remain unchanged. Janssen will get right to continue research on IL-23 receptor antagonists developed under a collaboration for 3yrs. following the closing of the amended agreement Janssen will lead all future studies …
The engineered viruses used to deliver gene therapies can spark complications and they can’t be re-dosed. Ring Therapeutics says viruses that evolved with humans can be better viral vectors and the startup has raised $117 million in new financing to continue its research.
Shots: The companies will initiate P-I/II study evaluating the safety and preliminary efficacy of BBP-398 in combination with both Opdivo as dual therapy & Opdivo + KRASG12C inhibitor as triplet therapy in NSCLC patients with KRAS mutations, as 1L & 2L treatment options BridgeBio will sponsor the study while BMS will provide nivolumab to the …
Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its own antibody platform, the company says Teneobio’s technology and drug assets will complement its own.
The hedge fund SS&C Technologies Holdings will be the majority stakeholder, while the two payers will each hold a minority interest in the PBM, dubbed DomaniRx. The joint venture will develop a claims adjudication platform to support its operations.
AC Immune is bolstering the Parkinson’s disease portion of its drug pipeline with a deal to acquire a therapeutic vaccine that Affiris is developing for the disorder. Switzerland-based AC Immune plans to advance its new asset to Phase 2 testing.
Shots: The companies collaborated to research, develop & commercialize small molecules directed against the GPR75 target with the potential to treat obesity and related co-morbidities The collaboration builds on the findings from the Regeneron Genetics Center of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated …
“Very satisfied” is the consensus of KOLs who participate in our SkyBoard virtual advisory board events. But, from what KOLs tell us, there are also plenty of other ways to improve such virtual events. Before we go on to them, a brief note on terminology: by “Virtual Ad Board” we don’t just mean a live …
Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.
An Incyte drug developed as a treatment for a rare type of anal cancer has fallen short of FDA approval. The regulator said it needs to see more clinical data that demonstrating clinical benefit for the antibody drug.
Adverum Biotechnologies still doesn’t know if its experimental gene therapy caused eye problems reported in April in one patient in its diabetic macular edema study. But four others have since developed similar problems, and the company will no longer continue to develop the therapy for that indication.
Caribou Biosciences’ CRISPR approach to cell therapy sparked strong investor interest, enabling the clinical-stage biotech to upsize its IPO and raise $304 million in the biggest life sciences IPO this week. Absci, Sophia Genetics, and Cytek Biosciences also priced IPOs.
Arvinas’ early clinical data for its targeted protein degradation drug for breast cancer drew partnering interest from several companies. Pfizer beat them all with a deal that pays the biotech $1 billion to share in the development and commercialization of this therapy.
Legislators threaten to ban settlements where branded companies “pay” generics makers to “delay” market entry, while drugmakers say the current framework balances competition and innovation. Who will prevail?
Seres Therapeutics’ ambitions to treat ulcerative colitis with a microbiome drug were dealt a setback as its experimental therapy failed in Phase 2 testing. The company plans a “rigorous scientific analysis” to assess what happened and to determine the next steps for the program.
The FDA has approved Bylvay, an Albireo Pharma drug that treats the severe itching experienced by patients with progressive familial intrahepatic cholestasis (PFIC). Prior to this approval, the only treatment options for the rare liver disorder were surgical.
Shots: Calliditas to receive $24M upfront and is eligible to receive ~$91M as regulatory and commercialization milestones along with royalties on net sales The companies collaborated to develop a new oral formulation that downregulates IgA1 by combining Calliditas’ drug-delivery expertise with STADA’s extensive marketing and sales platform for specialty and nephrology therapies The companies collaborated …
An amyotrophic lateral sclerosis drug from Amylyx Pharmaceuticals is being prepared for Phase 3 clinical testing on track to begin later this quarter. To support that research, the biotech has raised $135 million in financing.
Cancer drug developer Frontier Medicines already has a research partnership with AbbVie. Now the preclinical-stage biotech has raised $88.5 million for its own pipeline, including a drug that could offer advantages over a recently approved Amgen cancer therapy.
An efficient way to create patient-focused educational materials is putting together a strategic group focused on consumers, which includes a medical expert, allied health professionals and a primary care physician to develop the strategy as well as the specific assets to support that strategy.
A Cytokinetics drug in development for treating a rare heart disorder has promising Phase 2 data suggesting it could compete against a Bristol Myers Squibb drug currently under FDA review. Cytokinetics plans to advance its small molecule to Phase 3 testing by the end of this year.
An intranasal Covid-19 vaccine candidate from Meissa Vaccines could offer advantages compared to injectable ones. The company is still in early clinical development but the company now has data from monkey studies that further build the case for the vaccine.
Research organizations can participate in ethical data sharing today by considering participants’ privacy and security and balancing the need to protect their commercial interests with the need to share enough data to benefit medical research.
Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for connected devices, Software as a Medical Device (SaMD), and the go-to market strategies for the companies behind them.
Vaxneuvance, a Merck pneumococcal vaccine, is now approved by the FDA. The intramuscular shot protects against 15 pneumococcal strains—five fewer than the 20 covered by a Pfizer pneumococcal vaccine that the FDA approved in June.
Cancer drug developer Erasca, whose mission is to “erase cancer,” has raised $300 million from its IPO. The clinical-stage biotech addresses a single elusive cancer target; it has multiple programs taking multiple approaches, two of them in human testing and the rest on track to join them.
Shots: Under Dzuveo agreement, AcelRx to receive ~$55M as an up front and commercial milestones in addition to 35% to 45% revenue share on net sales of Dzuveo. AcelRx will manufacture and supply Dzuveo while Aguettant gets the right to commercialize Dzuveo in the EU As per second agreement, Aguettant has the right to receive …
Shots: IRLAB to receive ~$363M, including $28M as up front and ~$335M as development, regulatory and commercial milestones along with royalties on WW net sales of mesdopetam Ipsen get the exclusive WW rights to develop and commercialize mesdopetam (novel dopamine D3-receptor antagonist) which is currently being evaluated in P- IIb clinical trials for patients with …
Wugen, a biotech developing “off-the-shelf” natural killer and CAR T cell therapies, has raised $172 million in Series B financing. The company’s lead program has already reached human testing and the new capital will be used to continue that research and advance other pipeline programs to the clinic.
Startup PAQ Therapeutics is developing drugs work like Pac Man, gobbling up components of a cell associated with disease. The biotech has closed $30 million in financing to continue its research, with a neurodegenerative disorder as its lead disease target.
Eli Lilly has Protomer Technologies, a preclinical startup developing next-generation insulin that senses blood glucose levels and adjusts its activity accordingly. The technology could eliminate the need for multiple insulin injections throughout the day.
By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the disease by targeting a particular enzyme highly expressed in the central nervous system. But Biogen still has some catching up to do.
CMS plans to review and determine coverage for Biogen’s Aduhelm, the first new Alzheimer’s disease treatment in decades. But the jury is still out on the drug’s effectiveness. Not to mention, its hefty price tag — $56,000 — could drive up Medicare spending.
The FDA is cautioning that the Johnson & Johnson Covid-19 vaccine may cause a rare immune response affecting the nerves. A causal link has not been established and the side effect, when observed, is rare, but the vaccine information has been updated to reflect the potential risk.
Shots: Hutchmed receives $25M as milestones at 1st commercial sales of Orpathys in China & will receive fixed royalties of 30% based on all sales under the license agreement with AstraZeneca As per collaboration, Hutchmed is responsible for the clinical development, approvals, manufacturing & supply of Orpathys in China while AstraZeneca is responsible for its …
Shots: InnoCare to receive $125M as up front & is eligible to receive ~ $812.5M as development & commercial milestones, following the achievement of definite milestones along with royalties on sales of any product resulting from the collaboration Biogen to get exclusive rights for orelabrutinib to treat MS globally & other autoimmune diseases outside of …
ProfoundBio is developing a type of targeted cancer therapy called antibody drug conjugates. As the biotech looks ahead to clinical trials, it has raised more than $55 million in Series A funding.
Novo Nordisk is paying $100 million up front to acquire an experimental Prothena drug being developed to treat heart problems stemming from a misfolded protein. The deal is part of a broader strategy to expand into drugs for cardiovascular disease.
Over time, a variety of methods / approaches have been developed for the generation of viable therapeutic leads. These include the hybridoma technology, B-cell cloning, transgenic animal-based techniques, in vitro display methods (using phages, ribosomes, mRNA, and cDNA) and cell surface display methods (involving mammalian, yeast, and bacterial cells). Despite being responsible for the development …
The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, giving the pharma giant an alternative way to compete against medicines already marketed by AstraZeneca and Bayer.
A hemophilia A patient in a Sigilon Therapeutics clinical trial developed a well-known complication to treatments for the blood disorder. The potential problem for Sigilon is that its cell therapy is designed to avoid triggering such immune responses.
Who influences whom? Who’s connected to whom? Who collaborates with whom? These are some of the most important questions that should be answered when creating your target list of KOLs to engage with and building an effective KOL engagement strategy. Traditionally most KOL influence maps have been built by analysing publication or congress co-authorship …
Who influences whom? Who’s connected to whom? Who collaborates with whom? These are some of the most important questions that should be answered when creating your target list of KOLs to engage with and building an effective KOL engagement strategy. Traditionally most KOL influence maps have been built by analysing publication or congress co-authorship …
Xilis is developing technology that creates a living model of a patient’s tumor, then applies artificial intelligence to determine the best drug or drug combinations to treat the cancer. Clinical trials are planned to test this precision medicine approach and the biotech startup has raised $70 million to fund its research.
The drug label for Biogen Alzheimer’s disease drug Aduhelm has been revised to clarify that its use is for patients with mild forms of the neurodegenerative disorder. The change aligns the prescribing information with the patient population studied in clinical trials.
Eli Lilly is partnering with startup Verge Genomics in a move intended to add ALS drugs to its neuroscience pipeline. To date, Verge’s artificial intelligence technology has produced programs internal programs in ALS, Parkinson’s, and frontotemporal dementia.
A NeRRE Therapeutics drug that failed a clinical trial for refractory or unexplained chronic cough is getting a second shot as a potential treatment for chronic cough in patients with idiopathic pulmonary fibrosis, a rare lung disorder. The biotech raised £20M to proceed with Phase 2 testing.
Two months after Eli Lilly began an alliance with MiNA Therapeutics, a startup developing a new type of RNA therapy, the pharmaceutical giant is making a $15 million equity investment in its partner. MiNA is developing a new class of medicines called small activating RNA therapies.
Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that was evaluated in clinical trials. A larger study testing the prospective type 1 diabetes therapy teplizumab is ongoing and could provide the information the agency needs.
Shots: Abbisko to receive upfront, milestones and royalties on net sales of the therapy & hold the rights for all other countries & indications. Sperogenix gets an exclusive right to develop, manufacture & commercialize ABSK021 in mainland China, Hong Kong SAR and Macao SAR for non-oncology rare neurological diseases Sperogenix will be responsible for the …
Four years after a private equity acquisition took Parexel private, the contract research organization is being acquired by two private equity firms for $8.5 billion. It’s the latest in a series of acquisitions to hit the CRO sector this year.
GlaxoSmithKline is paying Alector $700 million up front to share in the development of the biotech’s two lead drugs, which offer potentially broad application in treating neurological disorders. Alector’s approach addresses the role immune cell dysfunction plays in neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease.
Shots: Denovo has licensed the global rights for idalopirdine including all rights to develop, manufacture and commercialize idalopirdine for all indications. Lundbeck gets an option to reacquire idalopirdine. If Lundbeck exercise the option, both the companies will share rights of the product in China and if not, Denovo will retain all global rights to the …
Shots: Kaken to receive an up front in cash and is eligible to receive milestones and royalties on the sales of the product. Almirall plans to have a pre-submission meeting with regulatory authorities in next year to prepare the approval of the product in the EU Almirall get the exclusive rights for the development and …
Acumen Pharmaceuticals’ IPO raised $160 million to fund clinical development of its Alzheimer’s disease drug candidate. Though that drug goes after the same target as Biogen’s recently approved Aduhelm, Acumen says its antibody has potential dosing and safety advantages.
Despite mounting court and legislative scrutiny of pharmacy and prescription benefit manager practices, Amazon has chosen to throw its hat into the discount pharmacy ring. Could Amazon “disrupt” prescription drug delivery?
Shots: Orchard to receive $17.5M up front including $10M in cash & $7.5M as equity investment at a premium to Orchard’s share and is also eligible to receive ~$189.5M as other milestones along with royalties on WW sales Pharming has granted WW rights to OTL-105 (ex vivo HSC gene therapy) & will be responsible for …
Shots: Beam to receive $50M up front and $25M as near-term milestones & will be eligible to receive other milestones along with royalties on sales, following the exercise of the option. The companies will work on 6 research programs focusing on C3 & other complement targets in the eye, liver, and brain Apellis holds exclusive …
Fresh off its first FDA approval, Apellis Pharmaceuticals is teaming up with Beam Therapeutics, a partnership that will use Beam’s base-editing technology to develop new therapies for complement system disorders. Apellis has committed to pay Beam $75 million to kick off the alliance.
Led by former Viela Bio CEO Bing Yao, ArriVent Biopharma secures rights to drugs from emerging biotech hubs, then develops them for Western markets. The biotech’s first asset is a cancer drug licensed from Shanghai-based Allist Pharmaceuticals.
Pardes Biosciences advanced from concept to drug candidate in less than nine months. The preclinical biotech is developing an oral antiviral for Covid-19 and other coronavirus infections and it is going public in a SPAC merger that will infuse it with $276 million.
Walmart struck a deal with Novo Nordisk to offer a heavily discounted, private-label version of its fast-acting analog insulin. But it still doesn’t solve the pricing problems patients have faced, with insulin costs skyrocketing in recent years.
Sanofi, already a global leader in vaccine production, has formed a new division that will focus exclusively on developing messenger RNA vaccines. The pharmaceutical giant is committing to spend €400 million annually on this new center’s mRNA R&D.
Orphazyme’s corporate restructuring comes less than two weeks after the FDA rejected arimoclomal, a drug developed to treat the rare Niemann-Pick disease type C. The company said it is now focused on securing regulatory approval in Europe and finding a path forward for the small molecule with the FDA.
Intellia Therapeutics has early clinical trial data showing that its CRISPR-based therapy for a rare disease can edit genes inside the body safely and effectively. The trial is ongoing, but the preliminary results suggest that Intellia’s approach could offer a cure.
The FDA has granted emergency use authorization to a Roche antibody as a treatment for hyperinflammation in patients hospitalized with severe Covid-19. The drug, Actemra, is an anti-inflammatory medication already approved for treating rheumatoid arthritis.
Systems Oncology has used its its artificial intelligence to discover small molecules in development under partnerships with large pharma companies. The R&D of the company, the biopharma startup winner in the Pitch Perfect contest at the recent MedCity News INVEST Conference, includes a new type of RNA drug.
Health Union, the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world’s largest network of patient leaders – advocates, community leaders, creators and influencers. Combining Health Union’s targeted scale and depth in the condition experience with WEGO Health’s breadth of patient leaders …
Shots: CytoReason reports the initiation of a project with Sanofi by utilizing its cell-centered models and deconvolution techniques to counsel mechanistic insights for each asthma endotype The focus of the project is to drive a better understanding of heterogeneity in asthma patients and identify stable and reproducible asthma endotypes alongwith associated diagnostic features by using …
Lyell Immunopharma and Verve Therapeutics are still preclinical, but they’re bring novel genetic approaches to the treatment of cancer and cardiovascular disease. Now the two companies can claim two of the biggest biotech IPOs of 2021 so far.
A Covid-19 vaccine candidate based on messenger RNA technology from CureVac is showing 47% efficacy according to an interim analysis of a pivotal study. The German company blames the poor showing to new viral variants circulating in the study population.
Shots: Atea Pharma achieved a milestone related to the development of AT-527 and is expecting to receive a related payment of $50M under its license agreement with Roche. The company believes that AT-527 is suitable for use in both pre-and post-exposure prophylactic settings and complementary to vaccines The companies are jointly developing AT-527 for the …
Mallinckrodt Pharmaceuticals received FDA approval for its engineered skin product, StrataGraft, a treatment for serious thermal burns. The product is the latest to be reviewed under a new designation for regenerative medicines.
The health technology company offers a platform that enables clinicians to more quickly and accurately complete specialty drug enrollment processes and communicate with specialty pharmacies. The goal is to simplify the administrative burden on providers and get patients quicker access to the medications they need.
Shots: Linnaeus will conduct 6 additional P-II cohorts evaluating LNS8801 + Keytruda in several cancer indications while the companies are currently evaluating the combination in patients who had previously responded to PD-1/L1 therapy and also LNS8801 as a monothx in patients unable to tolerate PD-1/L1 therapy due to serious immune-related AEs The companies will further …
A Sage Therapeutics depression drug that failed a pivotal study in 2019 has positive preliminary results from a new Phase 3 clinical trial, but the data also showed the therapy’s effects waned over time. Questions about zuranolone’s durability are relevant to Biogen, which committed $1.5 billion to Sage in large part due to the drug’s …
GlaxoSmithKline is paying iTeos Therapeutics $625 million up front to share in the development of an antibody that targets the TIGIT protein, a hot target in cancer immunotherapy R&D. The deal comes less than a month after rival Bristol Myers Squibb inked its own deal securing rights to a TIGIT-targeting Agenus drug.
Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.
The American Society of Clinical Oncology’ annual meeting featured news highlights from the Merck, Novartis, and other drug giants. Meanwhile, some small biotechs rode the coattails of their larger counterparts and others forged their own paths with promising early results for new cancer drug targets.
Shots: Verona Pharma to receive $40M including $25M upfront cash and $15M equity interest in Nuance Biotech, and is eligible to receive ~$179M in milestones along with royalties on net sales in Greater China (mainland China, Taiwan, Hong Kong and Macau) Verona Pharma granted Nuance Pharma exclusive right to develop & commercialize ensifentrine in Greater …
Over time, several innovative technologies have been developed to support the designing and manufacturing of various types of antibody products; however, the aforementioned processes are characterized by high costs and technical complexities, especially during the production and downstream processing steps. Therefore, it is challenging for new entrants and companies with limited resources and capital, to …
Senda Biosciences is developing drugs based on an understanding of intersystems biology—the way that humans interact with bacteria and plants. The startup, founded by Flagship Pioneering, has added $55 million to advance its three lead programs to clinical testing next year.
The clinical trial arena is changing rapidly, driven largely by the acceleration of telehealth usage and the potential provided by new data solutions. Panelists at MedCity INVEST Precision Medicine agreed that clinical trials will never be conducted in the same way again.
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. CIOs and directors of pharmaceutical companies and laboratories, research and manufacturing directors, clinicians, IT project managers, heads from manufacturing and packaging pharma technology companies will gather to discuss the Manufacturing and Packaging …
Shots: Merck to receive ~$1.2B to supply ~1.7M courses of molnupiravir to the US government, if its receives EUA or approval from the US FDA and expects to have 10M+ courses of therapy available by the end of 2021 The therapy is currently being evaluated in a P-III MOVe-OUT study in non-hospitalized patients with COVID-19. …
Minority groups get left out of clinical trials and studies for many reasons, including lack of access, awareness and trust in the healthcare system. But, according to panelists at MedCity INVEST Precision Medicine, researchers along with patient advocates can help tackle these hurdles by working together and being intentional in their approach.
The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are on Pfizer’s heels with vaccine candidates that aim to match or even beat the Pfizer pneumococcal vaccines.
Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer’s disease drug, Aduhelm. According to a timeline set by the regulator, that clinical trial is not expected to be complete until 2029.
Shots: The discontinuation is based on Janssen’s review of all available cusatuzumab data and in consideration of the evolving SOC for AML. Argenx regain its WW rights to cusatuzumab from Cilag The P-Ib ELEVATE interim data will support the development of the anti-CD70 Ab in AML, whereas argenx plans to evaluate options to enable a …
A Biogen Alzheimer’s drug that clears amyloid plaque from the brain has been granted accelerated approved by the FDA. The drug, which will be marketed as Aduhelm, is the first new FDA-approved Alzheimer’s treatment since 2003.
Cancer drug developer Merus has encouraging early results indicating its drug can address several different types of tumors characterized by NRG1, a rare gene fusion. The company believes the data could support a regulatory filing for the bispecific antibody drug.
Cancer is one of the leading causes of death worldwide, accounting for an estimated 0.6 million deaths in 2020, in the US alone. The World Health Organization has estimated the number of new cancer cases to rise by 70%, worldwide, over the next 20 years. It is a well-known fact that the conventional treatment options, …
Stablix Therapeutics is developing technology that uses small molecules to stabilize a protein, keeping it from going to a cell’s built-in disposal system. The startup now has $63 million in funding to further invest in the technology and advance its first molecules toward the clinic.
Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans to seek full FDA approval of its antibody cocktail later this summer.
Join us for an interactive, one-day digital event, where VPs, Directors and Heads of Supply Chain and Logistics come together to share their experiences, brainstorm challenges and take advantage of new opportunities in the global pharma supply chain industry. Helping you transform, redefine and innovate your supply chain strategy during these unprecedented times and beyond. …
J+D Forecasting has worked with one of Europe’s largest, leading biotechnology pioneers, helping to facilitate better, more collaborative forecasting for hundreds of colleagues across the continent. For the company’s most recent forecasting cycle, our experts have worked to incorporate Microsoft Teams as a core software, as well as extending Power BI, to enable regional users, and …
The inaugural Prostate Cancer Drug Development Summit is the only industry-led meeting uniting large pharma, biotech and pioneering academics with the ambitious objective of accelerating the clinical development of safe and effective therapies to treat prostate cancer. With sessions on both early and advanced stages of prostate cancer (Non-Metastatic Castrate-Resistant Prostate Cancer (nmCRPC) and Metastatic Castrate-Resistant Prostate Cancer (mCRPC), this is a conversation not …
Shots: The first patient has enrolled in P-III TETON study to evaluate the safety and efficacy of treprostinil (Inhalation Solution) or PBO in a ratio (1:1) in 396 adult patients with IPF The 1EPs of the study is the change in FVC from baseline@ 52 wks. and 2EPs include time to clinical worsening, time to …
Novartis reported Phase 3 study results for a targeted radiation therapy showing that treatment helped patients with advanced prostate cancer live longer. The company will present data from this pivotal study during the annual meeting of the American Society of Clinical Oncology.
Auris Medical has acquired Trasir Therapeutics, a startup developing technology that expands the delivery of RNA medicines to tissues beyond the liver. Going forward, Auris will sell or spin off its programs in hearing disorders and allergies and focus exclusively on RNA therapies.
The FDA has approved Brexafemme, a Scynexis antifungal drug, for treating vaginal yeast infections. The drug is the biotech’s first FDA-approved product and it also represents the first new antifungal drug class in 20 years.
MorphoSys is acquiring Constellation Pharmaceuticals and its late-stage myelofibrosis drug in a deal that values the epigenetics biotech at $1.7 billion. Germany-based MorphoSys will finance the acquisition with cash from a separate $2 billion deal with drug royalty acquirer Royalty Pharma.
Who will benefit? New and aspiring marketers and those wanting to refresh their marketing thinking and be fitter to handle today’s healthcare environment. Topics covered Overview of pharmaceutical marketing Pharmaceutical marketing strategy concepts and tools Effective market and competitor analysis Increasing impact through effective segmentation & targeting Building competitive advantage through creative product positioning The …
Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.
Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage.
Shots: Kyowa Kirin to receive ~$400M up front and an additional ~$850M as milestones along with royalties on future global sales. Both companies will share global development costs (Ex- Japan & the US) Amgen will responsible for the development, manufacturing, and commercialization of KHK4083 for all markets globally (Ex-Japan, where Kyowa Kirin will retain all …
Three life science companies went public in the last full week of May. The biggest IPO belonged to Centessa Pharmaceuticals, a company that raised $330 million to support its unconventional but not unprecedented approach to drug R&D.
FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.
FDA authorization of the Covid-19 antibody drug from Vir Biotechnology and GlaxoSmithKline adds a third antibody drug for treating early cases of the disease that are at risk of progressing to hospitalization. The companies say they plan to launch the drug, named sotrovimab, “in coming weeks.”
For the second time in the span of one year, a group of insurers has filed a lawsuit against CVS alleging it overcharged them for generic drugs. CVS refuted the claims, calling them “baseless.”
Myovant hormonal drug Myfembree has won FDA approval as a treatment for uterine fibroid bleeding. The regulatory decision clears the way for the pill to compete against a similar AbbVie drug, but with dosing and pricing advantages.
The FDA placed a clinical hold on a Larimar Therapeutics program for Friedreich’s ataxia after monkeys died in tests of the fusion protein. In addition to halting further tests of the drug, the clinical hold also ends the biotech’s plan to raise $95 million that would have funded clinical research.
Earlier this year, Healthware Group and Plexus Ventures formed an alliance to structure deals for the pharmaceutical industry in the development and commercialization of Digital Therapeutic (DTx) products. Given the increased attention and growth seen in the market, both companies are leveraging their expertise to become go-to partners for life sciences companies looking to incorporate DTx into their pipelines. Healthware …
IQVIA is paying nearly $200 million to purchase a Myriad Genetics subsidiary that provides pharmaceutical contract services , a deal that will put the new acquisition in the company’s Q2 Solutions unit, The deal follows IQVIA’s April announcement that it had secured full ownership of Q2, which had been a joint venture with Quest Diagnostics.
Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans to submit applications to regulators in early June seeking expansion of emergency authorization of the vaccine to include this younger age group.
After decades of struggling with poor public perception, the pharma industry has an opportunity to generate stronger connections with consumers than ever thanks to the COVID-19 vaccine drive – but it will have to move quickly. That is the conclusion of a Mediahub study which cites recent poll data in the US giving the industry …
An NGM Biopharmaceuticals drug candidate for the fatty liver disease NASH failed a Phase 2b study less than a year after the company reported positive results from an earlier mid-stage study. The biotech will now focus on programs in eye diseases and cancer that are partnered with Merck.
Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. Rybrevant is the first approved targeted therapy addressing a subset of patients whose disease is characterized by a particular mutation to cancer protein EGFR.
CVS has launched a new clinical trials services business that will help drug companies and contract research organizations recruit clinical trial volunteers. The new business unit builds on work the pharmacy giant did last year, identifying and recruiting recruit people for clinical trials testing Covid-vaccines and medicines.
Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology to accelerate and make more efficient the process of manufacturing the AAV viral vectors used in gene therapies.
Eli Lilly diabetes drug tirzepatide beat long-acting insulin in the last of a series of global studies designed to support regulatory submissions for the type 2 diabetes drug, a potential successor to blockbuster drug Trulicity. The Indianapolis-based drug giant said it expects to file for approval by the end of 2021.
Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.
BlueRock Therapeutics, a Bayer subsidiary, is teaming up with Opsis Therapeutics and Fujifilm Cellular Dynamics in an R&D pact focused on developing stem cell therapies for eye diseases. BlueRock is paying its new partners $30 million up front to kick off the alliance.
New investment company eureKARE aims to find promising microbiome and synthetic biology research in Europe and create new companies around that science. EureKARE has three startups in its portfolio, and it now has $60 million in Series A financing to build more.
Shots: Exscientia to receive ~$50M as up front, ~$125M as milestones and additional clinical, regulatory, and commercial milestones of over $1.2B along with royalties on net sales of any marketed therapies resulting from the collaboration The expanded collaboration has the potential to add to the BMS drug pipeline whilst enhancing Exscientia’s portfolio of shared assets. …
Shots: Mestag to receive option fees, milestones, royalties and will deploy its specialist fibroblast sub-population biology platform and state-of-the-art data analytics to identify novel therapeutic targets Janssen to get an option to exclusive license to develop and commercialize therapies directed against up to two targets emerges from the collaboration Apart form this collaboration, Mestag will …
Bristol Myers Squibb already has a cancer program targeting the TIGIT protein, but in acquiring rights to Agenus’s drug, the pharma giant adds a bispecific antibody that preclinical research suggests has the potential to be the best in this drug class. BMS agreed to pay $200 million up front for global rights.
Shots: Fujifilm and Opsis to receive $30M up front and ~$40M as R&D and part of manufacturing funding for the development of 3 programs. The companies are eligible to receive development & commercial milestones along with royalties on a per-program basis BlueRock to get an option to license the 3 programs on a program-by-program basis …
The FDA approved Apellis Pharmaceuticals drug pegcetacoplan (Empaveli) as a treatment for a rare blood disorder that is currently treated with medicines sold by Alexion Pharmaceuticals, a biotech being acquired by AstraZeneca. But Apellis’s drug beat Alexion drug Soliris in a head-to-head test, and the smaller company aims to steal market share from its larger …
Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s foundation in existing influenza vaccines offers advantages, and potentially gives their candidate a place in the market as a booster shot.
Vera Therapeutics raised $47.9 million from its IPO to continue clinical development of its lead asset, a potential treatment for the kidney disease IgA nephropathy. But the company is joining a crowded field of companies aiming to develop a drug for the rare disorder.
In a month where GoodRx’s stock has been trading below IPO levels, the startup’s leadership says Amazon Pharmacy still isn’t a threat. Citing third-party data, the company said uptake of Amazon’s pharmacy services have been low, though the retailer still could pose a threat with its growing healthcare business.
A Biogen gene therapy for a rare, inherited eye disorder that leads to blindness has failed a key clinical trial. The preliminary results are the latest blow to the company’s efforts to expand its scope to gene therapies.
Shots: The interim data from 18 patients out of 20 in P-II trial evaluating the safety, tolerability, and efficacy of MS1819 (700/1200/2240 mg, qd, for 15 days/dosing level) + PERT aged 12 yrs or older in CF patients for EPI The 1EP & 2EP of the trial demonstrated improvement in CFA, improvement in stool weight, …
Interline Therapeutics has technology that shows how proteins interact as communities, paving the way for the discovery of new drugs. CEO Zachary Sweeney, a Denali Therapeutics veteran, said the startup will use the $92 million in funding to advance programs in cancer and inflammatory diseases.
Heron Therapeutics is positioning its drug, Zynrelef, as a way to help patients avoid addictive opioid painkillers following surgery. The extended-release formulation offers analgesic effects over 72 hours—when postsurgical pain is most severe and more likely to require pain management medication.
As the push towards Digital HCP engagement intensifies, we have seen an increase in the number of requests for identifying Digital KOLs to help author and lead Digital HCP engagement initiatives. Here are some thoughts to help you navigate the Digital KOL identification journey: Digital KOLs don’t just mean those that are tweeting …
Shots: Biogen’s decision of acquisition of TMS-007 based on the safety, imaging, and clinical outcome data from the P-IIa study which showed positive impacts on both blood vessel reopening in the brain, as well as patient functional recovery with no incidence of sICH TMS to receive $18M upon acquisition of TMS-007 and is eligible to …
Biogen paid $18 million to acquire a drug that TMS Co. of Japan tested in patients with acute ischemic stroke. The acquisition follows the report of preliminary mid-stage data showing the drug led to no cases of a potentially fatal complication associated with currently available stroke therapies.
Perceptive Advisors has $515 million for its second fund investing in biotech startups. Portfolio Manager Chris Garabedian says Perceptive Xontogeny Ventures Fund II is looking to make Series A investments in early-stage companies with assets that can show a path to clinical testing.
Shots: Nanobiotix to receive a $20M up front and is eligible to receive ~$220 M as contingent payments and milestones along with royalties on net sales of NBTXR3 in the licensed countries LianBio to get exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore, and Thailand LianBio supports the expansion of …
Shots: Autobahn acquires global IP, development, and regulatory rights to ASP3652 to strengthen its brain-targeting chemistry platform. The addition of ASP3652 will accelerate the delivery of next-generation brain-targeting prodrugs for CNS disorders, particularly MS ASP3652 complements Autobahn’s brain-targeting chemistry platform, which uses FAAH-mediated prodrug conversion to enable the delivery of small molecules across the BBB. …
Ginkgo Bioworks, a company whose cell engineering work can be found in products ranging from food ingredients to vaccines, is going public in a SPAC deal that values it at $15 billion. The merger will infuse it with $2.5 billion in capital to invest in its platform technology.
The companies are supporting 12 culturally competent healthcare startups in a new accelerator. Two of them will get up to $200,000 in grant funding.
The FDA has expanded emergency use of the Pfizer/BioNTech Covid-19 vaccine to include children 12 to 15 years of age. Meanwhile, the regulator is planning an advisory committee meeting to discuss use of Covid vaccines in pediatric patients broadly.
Incubated by Flagship Pioneering, biotech firm Laronde is developing endless RNA, or eRNA, a new class of medicines that goes beyond messenger RNA-based therapies. Flagship is backing the startup $50 million in Series A financing.
The messenger RNA vaccine developed by Pfizer and BioNTech has been formally submitted for FDA approval. The application comes amid calls for all vaccine companies to waive patent protections on these products so that others will be able to manufacture them.
Three biotechs IPOs priced this week while one gene therapy developer postponed its plans. The biggest IPO belongs to Talaris Therapeutics, a company developing a cell therapy for organ transplant patients that could mean the end of lifelong immunosuppressive drugs that prevent rejection.
Shots: The collaboration will evaluate Fusion’s FPI-1434 + Merck’s Keytruda in patients with solid tumors expressing IGF-1R. Fusion will sponsor the study and Merck will supply Keytruda The companies plan to initiate a P-I/II trial to evaluate the safety, tolerability, and PK of combination therapy and is expected in ~6 to 9 mos. upon achieving …
Shots: BeiGene and Asieris collaborate to evaluate the safety and efficacy of APL-1202 + tislelizumab as neoadjuvant therapy in patients with MIBC. APL-1202 has been approved to treat patients with locally advanced or metastatic UC and high expression of PD-L1 who failed to receive platinum-based CT Asieris plans to submit INDs in China and the …
Becton Dickinson is known worldwide for its diabetes products. Now the medical technologies giant plans to spin off its diabetes care business as a separate, publicly traded company, leaving BD to focus on its other core segments.
Dyno Therapeutics’ technology for designing viral vectors that deliver gene therapies has led to partnerships with Novartis, Sarepta Therapeutics, and Roche. With the Series A financing, the startup plans to expand its technology to address more tissue types, and potentially add more partners.
Shots: ProQR is eligible to receive ~$115M up front and milestone along with royalties on the sales of any resulting products during the royalty term and gets the right to receive a percentage of equity in the form of Yarrow shares Yarrow has in-licensed exclusive rights for ProQR’s ASO technology to develop and commercialize potential …
Cell therapy manufacturing is currently a manual, multi-step process that takes weeks. Startup Cellares, which is developing a system that automates the process and makes manufacturing scalable, will use the Series B financing to accelerate its work.
Glasgow, UK – (March 29, 2021) – Formedix, a leading provider of clinical trial software solutions, announces the launch of ryze, an innovative all-in-one cloud-based clinical metadata repository (MDR) and study automation platform. ryze has been specifically developed to accelerate and streamline the design, build and submission of clinical trials, in compliance with the Clinical …
Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The merger deal that will take it public reveals how much new technology changed the company’s vision and its strategy.
Vaccitech and Werewolf Therapeutics joined the public markets, raising a combined $230 million. The vaccine developer and the cancer immunotherapy biotech will apply the IPO proceeds toward clinical development of their respective pipelines.
The list of FDA-approved antibody drug conjugates (ADC) is growing, and two more biotech startups have emerged from stealth with new cash and new approaches to this type of cancer drug. Adcendo and Adcentrx raised a combined $112 from their Series A financings.
Capsule, an online pharmacy startup that offers same-day prescription delivery, raised $300 million in funding. It plans to use the funds to build out an online marketplace for digital health solutions.
Adverum Biotechnologies reported that a diabetic macular edema patient treated with the biotech’s experimental gene therapy developed complications, including blindness, in the treated eye. The company has unmasked the study and is trying to identify potential risks to other patients.
Change is coming in the digital marketing world whether you’re ready or not. New challenges are presented for marketers as privacy measures tighten and we say goodbye to cookies, yet this impending farewell also presents an invaluable opportunity to rejuvenate your pharma brand strategy. As healthcare marketers prepare for the switch to flip, one thing is …
Boundless Bio’s research has uncovered a previously unknown driver of cancer growth and drug resistance. With $105 million in Series B financing, the biotech is on a path to bring to the clinic small molecules that address this target, called extrachromosomal DNA.
Amplyx Pharmaceuticals brings Pfizer a clinical-stage antifungal candidate with a novel mechanism of action. The pharmaceutical giant is trying to build its antifungal product lineup, which is currently led by a drug that has lost patent protection.
Seasonal allergy sufferers have a plethora of choices for treating the itching and redness affecting their eyes. An experimental Aldeyra Therapeutics drug that takes a new approach to blocking inflammation triggered by allergens has met the goals of a pivotal study and the biotech now plans to discuss the data with the FDA.
Several companies are developing immunotherapies targeting the “don’t eat me” cancer protein CD47. Arch Oncology, which is developing drugs with features that could set them apart from the field, now has $105 million for multiple clinical trials.
Shots: Esperion to receive $30M up front, ~$175M as sales milestones along with royalties from 5-20% on sales in the territory. Daiichi Sankyo will get exclusive commercialization rights to bempedoic acid and bempedoic acid/ezetimibe combination tablet in S. Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, Macao, Cambodia, and Myanmar The agreement allows for the expansion …
A uniQure gene therapy for hemophilia B that has been under a clinical hold for four months can now resume testing. The hold was lifted after uniQure answered the FDA’s questions about whether the gene therapy caused the liver cancer diagnosed in one patient who received the therapy.