Vertex Stops Test of Rare Disease Drug, Dimming Pipeline Prospects

Vertex Pharmaceuticals is halting work on an experimental drug for a rare protein deficiency after safety problems were reported in Phase 2 testing. The study was evaluating the small molecule, VX-814, as a treatment for alpha-1 antitrypsin deficiency, which can lead to liver and lung problems. After the markets closed Wednesday, Vertex (NASDAQ: [[ticker:VRTX]]) disclosed … Continue reading “Vertex Stops Test of Rare Disease Drug, Dimming Pipeline Prospects”

Codiak Bio’s IPO Brings In $82M as Exosome Clinical Trials Begin

Codiak BioSciences now has $82.5 million to fund clinical tests of a new class of medicines based on exosomes, tiny bubbles formed by cells that the company harnesses to carry therapeutic cargo. Late Tuesday, Codiak priced its offering of 5.5 million shares at $15 apiece, the midpoint of its projected $14 to $16 per share … Continue reading “Codiak Bio’s IPO Brings In $82M as Exosome Clinical Trials Begin”

Roche Enlists Dyno to Bring AI to Next-Generation Liver, CNS Gene Therapies

Roche made a splash with its acquisition of Spark Therapeutics, whose Luxturna, a gene therapy for an inherited form of vision loss, was the first such therapy to win FDA approval. Now the Swiss pharmaceutical giant is looking to bolster its capabilities in liver and central nervous system (CNS) disorder gene therapies and it’s turning … Continue reading “Roche Enlists Dyno to Bring AI to Next-Generation Liver, CNS Gene Therapies”

Despite Phase 2 Failure, Gossamer Bio Sees a Path for Drug in Asthma

Gossamer Bio’s lead drug, an experimental treatment for asthma and allergies, has failed in two mid-stage clinical trials but the biotech sees enough in the data to pursue further development in a severe form of asthma and it wants to talk with regulators about advancing the compound to a larger Phase 3 study. The Gossamer … Continue reading “Despite Phase 2 Failure, Gossamer Bio Sees a Path for Drug in Asthma”

Dewpoint Therapeutics Taps Ex-Sanofi Executive Ameet Nathwani as CEO

Ameet Nathwani has been appointed CEO of Dewpoint Therapeutics. He is also joining the Boston company’s board of directors. Earlier this year, Nathwani left his chief medical officer and chief digital officer roles at Sanofi (NYSE: [[ticker:SNY]]) as part of an executive team shakeup. His experience also includes 12 years at Novartis (NYSE: [[ticker:NVS]]) in … Continue reading “Dewpoint Therapeutics Taps Ex-Sanofi Executive Ameet Nathwani as CEO”

SQZ Biotech Lines Up an IPO on the NYSE to Fund Cell Therapy R&D

SQZ Biotechnologies, which already has an alliance with Roche focused on developing new cancer cell therapies, is now looking to sell shares to the public to finance its research of potential new treatments for both cancer and infectious disease. In paperwork filed with securities regulators late last week, SQZ set a preliminary $75 million goal … Continue reading “SQZ Biotech Lines Up an IPO on the NYSE to Fund Cell Therapy R&D”

“Opioid Stacking” Concerns Lead FDA to Reject Avenue Therapeutics Drug

An opioid that Avenue Therapeutics reformulated for treating post-surgical pain in hospital settings has been rejected by the FDA due to safety concerns. The Avenue (NASDAQ: [[ticker:ATXI]]) drug is an intravenous formulation of tramadol, an opioid that first reached the US market 25 years ago in pill form. Now New York-based Avenue is trying to … Continue reading ““Opioid Stacking” Concerns Lead FDA to Reject Avenue Therapeutics Drug”

FDA Panel Vote Weighs in Favor of Alkermes Psych Drug, With Caveats

An Alkermes antipsychotic treatment designed to offer the benefits of a commonly prescribed medicine, but without the weight gain side effect, won the backing of an FDA advisory committee on Friday. But even some of the panel members who supported the drug qualified their votes, expressing concern about what the drug could mean for patients … Continue reading “FDA Panel Vote Weighs in Favor of Alkermes Psych Drug, With Caveats”

Bio Roundup: CRISPR Kudos, Bristol Myers’s Buy, RNAi Alliance & More

It’s October: a time of days growing shorter, leaves changing color, and phone calls in the wee hours that rouse scientists from slumber notifying them they’ve won the highest honor in their fields. This week, the 2020 Nobel Prize in physiology or medicine was awarded to Harvey Alter, Michael Alton, and Charles Rice, whose research … Continue reading “Bio Roundup: CRISPR Kudos, Bristol Myers’s Buy, RNAi Alliance & More”

In RNAi Move, Takeda Fronts $300M to Team Up on Arrowhead Liver Drug

Arrowhead Pharmaceuticals’ gene silencing treatment for a rare liver disease will move through the regulatory process and potential commercialization with the muscle of Takeda Pharmaceutical behind it. Takeda (NYSE: [[ticker:TAK]]) has agreed to pay $300 million up front in a partnership on Arrowhead (NASDAQ: [[ticker:ARWR]]) drug ARO-AAT as a treatment for alpha-1 antitrypsin-associated liver disease. … Continue reading “In RNAi Move, Takeda Fronts $300M to Team Up on Arrowhead Liver Drug”

Scribe Therapeutics Sets Out to Write CRISPR Gene Editing’s Next Chapter

The first generation of CRISPR-based therapies showed how the technology can edit DNA, making genetic fixes to unwanted mutations. But those treatments use the CRISPR system as scientists found it in nature, which means it still has limitations when applied to humans, says Benjamin Oakes, CEO of Scribe Therapeutics. Scribe aims to develop gene-editing therapies … Continue reading “Scribe Therapeutics Sets Out to Write CRISPR Gene Editing’s Next Chapter”

Federation Bio Bags $50M to Engineer New Approach to Microbiome Drugs

Scientists at microbiome therapy developers often talk about the importance of community, how the bugs in our gut act in concert in addition to their individual roles. That’s important for microbiome health and for microbe-based therapies, says Emily Drabant Conley, CEO of startup Federation Bio. Conley’s company is developing therapies that build on the understanding of … Continue reading “Federation Bio Bags $50M to Engineer New Approach to Microbiome Drugs”

Bristol Myers to Buy MyoKardia, FDA-Ready Heart Disease Drug for $13.1B

Bristol Myers Squibb is bolstering its cardiovascular drug lineup with a $13.1 billion deal to acquire MyoKardia, a company whose experimental therapy for a rare type of heart disease is on track for an FDA submission and is projected to become a blockbuster seller, if approved. According to financial terms announced Monday, Bristol (NYSE: [[ticker:BMY]]) … Continue reading “Bristol Myers to Buy MyoKardia, FDA-Ready Heart Disease Drug for $13.1B”

Bio Roundup: MESO’s Miss, Pfizer’s Cancer Bet, Vaccine Promise & More

Amid the bombast of Tuesday’s presidential debate, viewers caught some discussion about the response to the coronavirus pandemic and efforts to develop a COVID-19 vaccine. In the crosstalk, the president made an unsupported claim that we are weeks away from having vaccines. It’s true that some pharmaceutical companies are already manufacturing their COVID-19 vaccine candidates … Continue reading “Bio Roundup: MESO’s Miss, Pfizer’s Cancer Bet, Vaccine Promise & More”

FDA Lifts Solid Bio Clinical Hold, Duchenne Study Cleared to Resume

Solid Biosciences has answered the FDA’s outstanding questions about its Duchenne muscular gene therapy, clearing a clinical trial to now resume after patient complications last year led the agency to halt the study for a second time. Cambridge, MA-based Solid Bio (NASDAQ: [[ticker:SLDB]]) said Thursday that it expects dosing of patients in the Phase 1/2 … Continue reading “FDA Lifts Solid Bio Clinical Hold, Duchenne Study Cleared to Resume”

Genfit Restructuring Cuts Staff by 40%, Creates Two New Subsidiaries

[Updated 10/1/2020. See below.] Genfit is halting all work on its lead drug in the fatty liver disorder nonalcoholic steatohepatitis (NASH) and implementing a corporate restructuring that will cut 40 percent of its staff, splitting the remaining workforce into two distinct business units. The announcement after the market close on Wednesday follows the May failure … Continue reading “Genfit Restructuring Cuts Staff by 40%, Creates Two New Subsidiaries”

Invetx Appoints Bill Brondyk, Colin Giles to Executive Team

Invetx has appointed Bill Brondyk to serve as its chief scientific officer. His experience includes posts at Ohana Therapeutics and Sanofi (NYSE: [[ticker:SNY]]). Boston-based Invetx also named Colin Giles, a veteran of Nexvet Biopharma and Pfizer Animal Health, to become its chief development officer. Invetx uses the science underlying biologic drugs for humans to develop … Continue reading “Invetx Appoints Bill Brondyk, Colin Giles to Executive Team”

Thrive Earlier Detection Taps CVS’s Asgarian as Chief Medical Officer

Cancer diagnostics developer Thrive Earlier Detection has named Sam Asgarian its chief medical officer. He joins Thrive from CVS Health (NYSE: [[ticker:CVS]]), where he was vice president of the company’s transformation health product divison. He came to CVS via its acquisition of Aetna. In other moves, Dina Ciarimboli, who had been serving as interim general … Continue reading “Thrive Earlier Detection Taps CVS’s Asgarian as Chief Medical Officer”

Pfizer Pumps $200M Into CStone for Rights to PD-L1 Cancer Drug in China

CStone Pharmaceuticals has touted its experimental drug sugemalimab as potentially the best in its class of cancer immunotherapies. Pfizer is placing a bet on that promise by making a $200 million equity investment in CStone for rights to that drug in China. According to deal terms announced late Tuesday, Pfizer (NYSE: [[ticker:PFE]]) is purchasing nearly … Continue reading “Pfizer Pumps $200M Into CStone for Rights to PD-L1 Cancer Drug in China”

With Phase 2 Data in Hand, Ovid Eyes Multiple Pivotal Trials for Epilepsy Drug

Ovid Therapeutics and Takeda Pharmaceutical joined forces three years ago to develop a small molecule into a potential epilepsy drug. That research is starting to pay off as the companies now look ahead to pivotal studies testing that compound in several inherited forms of the disorder. On Wednesday, New York-based Ovid (NASDAQ: [[ticker:OVID]]) reported Phase … Continue reading “With Phase 2 Data in Hand, Ovid Eyes Multiple Pivotal Trials for Epilepsy Drug”

Orphazyme Stock Sale Reaps $83M as Neimann-Pick Drug Review Begins

Orphazyme has fresh cash from the sale of shares in the US and Europe, which will support its lead rare disease drug through regulatory review and, if approved, a launch. But the drug fell short in key clinical trial measures, raising questions about its approvability. Now the FDA wants additional data, potentially throwing a wrench … Continue reading “Orphazyme Stock Sale Reaps $83M as Neimann-Pick Drug Review Begins”

Praxis Precision Medicines Leads Way as Three More Biotechs Prep IPOs

Praxis Precision Medicines kept mostly quiet about its research on central nervous system disorder (CNS) drugs until May, when it emerged from stealth and revealed $100 million in cumulative financing. Now the company is aiming to raise about that amount in an IPO that will fund clinical development of its drug pipeline. Cambridge, MA-based Praxis … Continue reading “Praxis Precision Medicines Leads Way as Three More Biotechs Prep IPOs”

Ex-Radius Health Exec Carmona Joins Rubius as Chief Financial Officer

Rubius Therapeutics (NASDAQ: [[ticker:RUBY]]) has appointed Jose “Pepe” Carmona to serve as its chief financial officer, the same position he held most recently at Radius Health (NASDAQ: [[ticker:RDUS]]). Cambridge, MA-based Rubius is engineering red blood cells into potential therapies. Earlier this year, Rubius stopped work on its lead drug candidate for a rare metabolic disorder … Continue reading “Ex-Radius Health Exec Carmona Joins Rubius as Chief Financial Officer”

Freeline Therapeutics Promotes Corbau to Chief Scientific Officer

Gene therapy developer Freeline Therapeutics (NASDAQ: [[ticker:FRLN]]) has promoted Romuald Corbau to chief scientific officer. He joined London-based Freeline in 2017 as vice president of research. Amit Nathwani, the company’s founder and outgoing chief scientific officer, will remain with the company as clinical and scientific adviser and member of the board of directors. Freeline is … Continue reading “Freeline Therapeutics Promotes Corbau to Chief Scientific Officer”

Galecto Picks Up $64M as Plans for Fibrosis Clinical Trials Move Forward

Had things turned out differently, scientists at Galecto might be watching their idiopathic pulmonary fibrosis drug candidate develop in the hands of a big pharmaceutical company. But Bristol Myers Squibb passed on its option to acquire Galecto leaving the biotech to forge ahead on its own. Now the company has $64 million to advance clinical … Continue reading “Galecto Picks Up $64M as Plans for Fibrosis Clinical Trials Move Forward”

Bio Roundup: Grail Acquisition, Libra’s Launch, Tau Trial Results & More

In biotech, you can go home again. Four years ago, Illumina spun out cancer diagnostics startup Grail. This week, the gene sequencing giant announced it is acquiring Grail in an $8 billion cash and stock deal. Grail set out with the goal of developing a diagnostic test that detects cancer from the genetic snippets tumors … Continue reading “Bio Roundup: Grail Acquisition, Libra’s Launch, Tau Trial Results & More”

Monte Rosa Raises $96M for “Glue-Based” Protein Degrading Drugs

Many drugs work by binding to a protein and blocking it. Technology for eliminating disease-causing proteins altogether remains experimental, but this approach has gained ground in the past year with hundreds of millions of dollars raised and compounds advanced into clinical testing. Monte Rosa is one of the newer companies in this “protein degradation” space … Continue reading “Monte Rosa Raises $96M for “Glue-Based” Protein Degrading Drugs”

Libra Strikes a Balance With Approach to ALS and Other Neuro Disorders

Amyotrophic lateral sclerosis (ALS) has no cure and few available treatments but the past decade has revealed new knowledge about the pathology of the disease. Libra Therapeutics is turning that research into potential therapies, and it now has $29 million to advance its work. While the exact causes of many neurological disorders are unknown, Libra … Continue reading “Libra Strikes a Balance With Approach to ALS and Other Neuro Disorders”

Tau-Targeting Alzheimer’s Drug from AC Immune, Roche Fails in Phase 2

An Alzheimer’s disease drug from partners AC Immune and Roche has failed a mid-stage clinical trial, adding another compound to the list of experimental therapies that have fallen short of demonstrating that they can treat the neurodegenerative disorder. The drug, semorinemab, was tested in patients with early Alzheimer’s disease. It did not achieve the Phase … Continue reading “Tau-Targeting Alzheimer’s Drug from AC Immune, Roche Fails in Phase 2”

Athira CEO Kawas: Alzheimer’s Drug Aims for “Recovery of Brain Function”

The key to Athira Pharma’s approach to Alzheimer’s disease is already inside each of us: a repair mechanism that can regenerate damaged neurons. What’s needed to begin the process is a pharmacological kickstart. Athira (NASDAQ: [[ticker:ATHA]]) is developing a drug intended to turn on the repair pathway. The company’s experimental therapy is a small molecule … Continue reading “Athira CEO Kawas: Alzheimer’s Drug Aims for “Recovery of Brain Function””

Illumina to Acquire Cancer Diagnostics Developer Grail in $8B Deal

[Updated, 3:45 pm ET.] Grail is set to be acquired for $8 billion by Illumina, the gene sequencing giant that formed the cancer diagnostics developer and spun it out as a separate company four years ago. The announcement comes less than two weeks after Menlo Park, CA-based Grail revealed its plans for an IPO to … Continue reading “Illumina to Acquire Cancer Diagnostics Developer Grail in $8B Deal”

Bio Roundup: SeaGen Scores, Dyne’s Debut, Microbiome Moves & More

Gilead Sciences CEO Daniel O’Day has spoken openly about acquisitions as a way to build up the company’s drug pipeline. This week, it made its biggest buy yet. The $21 billion Immunomedics acquisition brings to Gilead a cancer drug that many analysts project will become a blockbuster seller. Some of those analysts think Gilead might … Continue reading “Bio Roundup: SeaGen Scores, Dyne’s Debut, Microbiome Moves & More”

Dyne’s Upsized IPO Brings In $233M for Muscle Disorders Drug R&D

Dyne Therapeutics, a company developing genetic medicines for rare muscular disorders, has raised $233 million in an IPO that topped the preclinical-stage biotech’s projections. Late Wednesday, Dyne priced its offering of about 12.3 million shares at $19 each. The Waltham, MA-based biotech had previously planned to sell 10.3 million shares in the range of $16 … Continue reading “Dyne’s Upsized IPO Brings In $233M for Muscle Disorders Drug R&D”

Finch Therapeutics Fetches $90M to Advance Microbiome Drug Pipeline

When Seres Therapeutics reported positive late-stage data for its experimental microbiome treatment last month, scientists at Finch Therapeutics cheered the results from the rival company whose lead drug candidate addresses the same gut infection they aim to treat. Positive data, no matter the source, helps the entire microbiome therapies field and paves the way for … Continue reading “Finch Therapeutics Fetches $90M to Advance Microbiome Drug Pipeline”

Arrowhead Pharma Shares Soar on Early Liver Data for RNAi Drug

An Arrowhead Pharmaceuticals drug for a rare liver disease now has early Phase 2 results and the data so far look good. Not only did the therapy reduce levels of a mutant protein associated with the disorder, but patients also showed improvements in several biological measures of liver injury. The results are for just four … Continue reading “Arrowhead Pharma Shares Soar on Early Liver Data for RNAi Drug”

Neogene Therapeutics Grabs $110M to Tackle Solid Tumors With Cell Therapy

Cell therapy offers another option for addressing the most difficult blood cancer cases, but such treatments, which are engineered from a patient’s own immune cells, don’t yet work on solid tumors. Neogene Therapeutics is developing technology with the potential to bring cell therapies to solid tumors and it now has $110 million to advance its … Continue reading “Neogene Therapeutics Grabs $110M to Tackle Solid Tumors With Cell Therapy”

Unity Bio Restructuring Cuts 30% of Staff, Keeps Focus on Eye Drug

Unity Biotechnology is cutting nearly one third of its staff, a move that comes a month after the biotech’s lead drug candidate failed a mid-stage study in osteoarthritis. South San Francisco-based Unity (NASDAQ: [[ticker:UBX]]) says that the corporate restructuring announced Tuesday should make the cash that it has left last through mid-2022, when data are … Continue reading “Unity Bio Restructuring Cuts 30% of Staff, Keeps Focus on Eye Drug”

Silence Therapeutics Taps Orchard’s Mark Rothera as President & CEO

Mark Rothera has been appointed president and CEO of Silence Therapeutics (NASDAQ: [[ticker:SLN]]). He comes to London-based Silence from Orchard Therapeutics (NASDAQ: [[ticker:ORTX]]), where he was chief executive. Rothera’s experience also includes positions at PTC Therapeutics (NASDAQ: [[ticker:PTCT]]), Aegerion Pharmaceuticals, and Shire. Rothera is starting at Silence one week after the company debuted on the … Continue reading “Silence Therapeutics Taps Orchard’s Mark Rothera as President & CEO”

Synlogic Names Metera’s David Hava as Chief Scientific Officer

David Hava has joined Synlogic (NASDAQ: [[ticker:SYBX]]) as chief scientific officer, the same position he held most recently at Metera Pharmaceuticals. He also previously served as chief scientific officer of Pulmatrix (NASDAQ: [[ticker:PULM]]). Cambridge, MA-based Synlogic is engineering bacteria to serve as “living medicines.” The biotech’s lead program, SYB1618, is in mid-stage development as a … Continue reading “Synlogic Names Metera’s David Hava as Chief Scientific Officer”

Seattle Genetics Lands $1.72B From Merck in Pair of Cancer Drug Deals

Seattle Genetics is in line to receive $1.72 billion from Merck via a pair of deals, one for a cancer drug that’s still in development and the other for partial rights to a therapy that won FDA approval earlier this year. The larger of the two deals is for the drug still in clinical development, … Continue reading “Seattle Genetics Lands $1.72B From Merck in Pair of Cancer Drug Deals”

Gilead Adds “Cornerstone” Cancer Drug in $21B Immunomedics Buyout

Gilead Sciences is acquiring Immunomedics in a $21 billion deal, the latest in a string of transactions the company has made to bolster its cancer drug portfolio. The acquisition announced Sunday comes five months after Morris Plains, NJ-based Immunomedics won FDA approval for cancer drug sacitizumab govitecan (Trodelvy). The regulatory decision covers triple negative breast … Continue reading “Gilead Adds “Cornerstone” Cancer Drug in $21B Immunomedics Buyout”

Bio Roundup: COVID-19 Pact, Gavreto Approval, Generative Biology & More

COVID-19 research efforts are often characterized as a race between companies, a description that reflects the urgency to develop a vaccine for the novel coronavirus. The description is not quite right. A race has one winner and public health officials have said we’ll need multiple vaccines to address the global need. Vaccine developers have progressed … Continue reading “Bio Roundup: COVID-19 Pact, Gavreto Approval, Generative Biology & More”

Now Closer to Clinical Trials, Codiak BioSciences Refiles IPO Plans

Codiak BioSciences, a company developing therapies based on tiny bubbles secreted by cells, is lining up an IPO as it prepares for the first tests of its technology in humans later this year. In paperwork filed with securities regulators late Wednesday, Codiak set a preliminary $100 million goal for its stock market debut. The Cambridge, … Continue reading “Now Closer to Clinical Trials, Codiak BioSciences Refiles IPO Plans”

Satsuma Pharma’s Migraine Drug Fails to Beat Placebo in Phase 3 Test

[Updated, 7:31 p.m. EDT. See below.] An experimental Satsuma Pharmaceuticals treatment for acute migraine has failed a late-stage clinical trial, dealing a setback to the company’s plans to offer another therapeutic option to the millions of people who suffer from the condition. In Phase 3 results released Thursday, South San Francisco-based Satusuma (NASDAQ: [[ticker:STSA]]) reported … Continue reading “Satsuma Pharma’s Migraine Drug Fails to Beat Placebo in Phase 3 Test”

Generate Bio Aims to Reveal Nature’s Protein Secrets, Create New Drugs

When biotech startups emerge from stealth, executives typically talk about new molecules in the pipeline and novel approaches they take to treating a disease. The founders of Generate Biomedicines want to discuss none of those things, yet they contend their technology will upend the way protein drugs are discovered and developed. Cambridge, MA-based Generate has … Continue reading “Generate Bio Aims to Reveal Nature’s Protein Secrets, Create New Drugs”

Grail Files to Go Public; 5 More Life Science Firms Join the IPO Queue

Grail, a company developing blood tests intended to detect cancer well before symptoms show, is taking its pitch to a broader swath of investors. The diagnostics company is looking ahead to potential commercialization of its technology as early as next year, and it has filed for an initial public offering to support its plans. In … Continue reading “Grail Files to Go Public; 5 More Life Science Firms Join the IPO Queue”

Agios Exec Andrew Hirsch Jumps to C4 Therapeutics for CEO Role

Andrews Hirsch has joined C4 Therapeutics as its new CEO. He comes to the Watertown, MA-based biopharmaceuticals company from Agios Pharmaceuticals (NASDAQ: [[ticker:AGIO]]), where he was chief financial officer and head of corporate development. Marc Cohen, the co-founder and interim CEO of C4, will remain executive chairman of the company. C4 is developing drugs that … Continue reading “Agios Exec Andrew Hirsch Jumps to C4 Therapeutics for CEO Role”

AlloVir Taps Merck’s Atillasoy as Chief Regulatory & Safety Officer

AlloVir (NASDAQ: [[ticker:ALVR]]) has appointed Ercem Atillasoy to serve as its chief regulatory and safety officer, a new position. He joins the Cambridge, MA-based cell therapy developer after a nearly 20-year career at Merck (NYSE: [[ticker:MRK]]). He most recently worked at Merck Research Laboratories, where he was vice president and therapeutic area head of vaccines … Continue reading “AlloVir Taps Merck’s Atillasoy as Chief Regulatory & Safety Officer”

Grifols Moves Deeper Into Proteome R&D With $146M Deal for Alkahest

Alkahest, a company that analyzes blood proteins to develop therapies that address neurological disorders including Alzheimer’s disease, is set to be acquired by partner Grifols in a $146 million deal. Grifols (NASDAQ: [[ticker:GRFS]]) announced Tuesday that it is acquiring the shares of privately held Alkahest that it does not already own. Barcelona, Spain-based Grifols says … Continue reading “Grifols Moves Deeper Into Proteome R&D With $146M Deal for Alkahest”

FDA Approves Blueprint Cancer Drug Targeting RET Genetic Signatures

[Updated, 9/8/2020. See below.] A Blueprint Medicines drug for cancers that carry a certain genetic signature has received FDA approval, making it the latest targeted therapy to pass the regulatory bar this year. The late Friday decision for pralsetinib (Gavreto) covers non-small cell lung cancer (NSCLC). The drug was designed to address cancers characterized by fusions … Continue reading “FDA Approves Blueprint Cancer Drug Targeting RET Genetic Signatures”