Category: National

Lax Approval Requirements Yield Blockbusters That Don’t Work

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored. I met the management of InterMune almost 20 years ago when it was a mid-sized US biotechnology company … Continue reading “Lax Approval Requirements Yield Blockbusters That Don’t Work”

Bio Roundup: Pandemic Declared, Rubius Restarts, Kymera’s Cash & More

The financial markets are tumbling, event cancellations are mounting, and sports leagues are suspending their seasons. March Madness is in full swing but not in any way that people wanted or expected. The World Health Organization this week declared that the COVID-19 outbreak was serious enough to classify as pandemic. The toll on public health … Continue reading “Bio Roundup: Pandemic Declared, Rubius Restarts, Kymera’s Cash & More”

Rubius Drops Rare Diseases, Turns to Cancer and Autoimmune Disorders

Rubius Therapeutics is dropping its lead drug candidate—and its focus on rare diseases—in favor of earlier-stage cell therapies that it has been developing for oncology and autoimmune disorders. The Cambridge, MA-based company disclosed the strategy shift Thursday in its report of fourth quarter and full year 2019 financial results. After the announcement, shares of Rubius … Continue reading “Rubius Drops Rare Diseases, Turns to Cancer and Autoimmune Disorders”

Harbour BioMed Tacks on $75M to Advance Broad Biologics Pipeline

A biotech born out of an antibody platform company has added another $75 million to its investment haul, money it says will allow it to advance its clinical-stage compounds and continue to build its portfolio of earlier-stage therapeutics. Shanghai-based Harbour BioMed emerged in 2016 after acquiring technology developed by Harbour Antibodies, a Dutch company that … Continue reading “Harbour BioMed Tacks on $75M to Advance Broad Biologics Pipeline”

Imara Dives Into Coronavirus-Churned Financial Waters With a $75M IPO

The global economy is in tumult as the new coronavirus sparks financial contagion but drug developer Imara pressed ahead with its IPO anyway, raising $75.2 million in its stock market debut. Late Wednesday, Imara offered 4.7 million shares for $16 apiece, which was the low end of its projected price range. The Boston-based company had … Continue reading “Imara Dives Into Coronavirus-Churned Financial Waters With a $75M IPO”

Kymera Closes $102M Round to Bring Protein-Busting Drugs to the Clinic

Reuse and recycle is more than an environmental slogan. It’s also a succinct description of how cells deal with old or damaged proteins. Kymera Therapeutics is developing drugs that use this cyclical cellular process to treat disease, and it has raised $102 million to move into clinical testing next year. The Series C round of … Continue reading “Kymera Closes $102M Round to Bring Protein-Busting Drugs to the Clinic”

Xcelerating Life Sciences San Diego Will Be Delivered Digitally

At Xconomy, we are here to serve the global biotech community and help biotech and pharma companies connect, do business, and find investment opportunities. We take this role seriously, and over the last week we have been engaged with many of you on how to deliver the value that Xcelerating Life Sciences San Diego provides … Continue reading “Xcelerating Life Sciences San Diego Will Be Delivered Digitally”

With Bristol and Otsuka on Board, LSP Raises $620M EU Life Sciences Fund

Healthcare investment firm LSP has raised what it says is the largest ever European fund focused on life sciences ventures. The Amsterdam, Netherlands-headquartered firm aimed to bring in $450 million in the final fundraiser for its LSP 6 life science private equity fund but has ended up with $620 million (€550 million) to invest in … Continue reading “With Bristol and Otsuka on Board, LSP Raises $620M EU Life Sciences Fund”

Silverback Therapeutics Adds $79M to Test HER2+ Tumor-Targeting Drug

In the four years that Silverback Therapeutics has been developing cancer immunotherapies that avoid dangerous side effects, the biotech has mostly kept a low profile. Now the company has $78.5 million in cash to advance that research, and it’s starting to open up about its work. The Series B round of funding brings the Seattle-based … Continue reading “Silverback Therapeutics Adds $79M to Test HER2+ Tumor-Targeting Drug”

Acceleron Drops Drug for Rare Muscle Disease After Mixed Phase 2 Data

An experimental Acceleron Pharma drug for rare neuromuscular diseases has failed to distance itself from a placebo in a mid-stage study, spelling the end for that program. Acceleron (NASDAQ: [[ticker:XLRN]]) drug ACE-083 was being developed as a treatment for Charcot-Marie-Tooth disease, a hereditary nerve disorder that leads to the progressive loss of muscle function. The … Continue reading “Acceleron Drops Drug for Rare Muscle Disease After Mixed Phase 2 Data”

Kala to Take Another Shot at FDA Approval With New Dry Eye Drug Data

A Kala Pharmaceuticals dry eye disease drug that was rejected by the FDA is now being readied for another regulatory filing based on new data. Last August the FDA rejected a Kala (NASDAQ: [[ticker:KALA]]) product meant to temporarily relieve signs and symptoms of dry eye disease. On Monday the Watertown, MA-based biopharma announced preliminary results … Continue reading “Kala to Take Another Shot at FDA Approval With New Dry Eye Drug Data”

Cushing’s Disease Drug That Novartis Sold to Recordati Nabs FDA Nod

A Cushing’s disease drug whose rights Novartis sold to Italy-based Recordati last year now has FDA approval. Cushing’s disease is a rare disorder in which the adrenal glands make too much of a hormone called cortisol. The Novartis (NYSE: [[ticker:NVS]]) drug, osilodrostat (Isturisa), is intended to block an enzyme key to cortisol production. The FDA … Continue reading “Cushing’s Disease Drug That Novartis Sold to Recordati Nabs FDA Nod”

Zentalis Leads a Trio of Biotechs Charting a Course for Wall Street

Cell therapies and antibody drugs grab much of the attention and investment in cancer drug development but the scientists at Zentalis Pharmaceuticals contend that there’s a place for small molecules too. Now the biotech is preparing for an initial public stock offering to advance its pipeline, which includes a lead candidate in testing in combination … Continue reading “Zentalis Leads a Trio of Biotechs Charting a Course for Wall Street”

Bio Roundup: Gilead’s $4.9B Deal, COVID-19 Collabs, IPO Plans & More

Last month, Gilead Sciences CEO Daniel O’Day announced plans to introduce 10 “transformative medicines” over the next 10 years. Acquisitions would help meet that ambitious goal, and this week Gilead announced one of them: a nearly $5 billion deal for cancer immunotherapy developer Forty Seven. Forty Seven’s lead CD47-blocking drug—the company is named after the … Continue reading “Bio Roundup: Gilead’s $4.9B Deal, COVID-19 Collabs, IPO Plans & More”

Roche Trial of Ionis Huntington’s Disease Drug Halted After Side Effects

A 20-patient Phase 1 study of an RNA drug discovered by Ionis Pharmaceuticals that is being tested as a treatment for Huntington’s disease by Roche was suspended after two reports of infections related to a device used to take samples of cerebral spinal fluid during the trial. The suspension doesn’t appear to be related to … Continue reading “Roche Trial of Ionis Huntington’s Disease Drug Halted After Side Effects”

MacroGenics Chief Medical Officer Jon Wigginton Announces Resignation

MacroGenics (NASDAQ: [[ticker:MGNX]]) says its chief medical officer, Jon Wigginton, will leave the Rockville, MD-based company as of March 27. The company said Wigginton, who joined MacroGenics in 2003, plans to resign “to pursue a new opportunity.” As MacroGenics, which is development antibody drugs for cancer, searches for a new CMO, its senior vice president … Continue reading “MacroGenics Chief Medical Officer Jon Wigginton Announces Resignation”

Culture Biosciences Adds $15M for New Software, Bioreactor Expansion

Culture Biosciences, a contract development and manufacturing organization, has added new funding to increase bioreactor capacity and create additional monitoring software. The San Francisco startup announced the completion of a $15 million Series A financing round this week, bringing aboard fresh cash from new venture capital backers in addition to earlier investors. Culture Biosciences said … Continue reading “Culture Biosciences Adds $15M for New Software, Bioreactor Expansion”

Melinta’s Chapter 11 Auction Draws No Bids, Deerfield to Get Assets

The assets of Melinta Therapeutics will go to creditor Deerfield Management after no bidders for the company emerged, the antibiotics developer announced Wednesday. Under a court-approved Chapter 11 bankruptcy plan, any bids for the company were due by March 2. An auction was scheduled for March 6 in the event any bids were submitted. But … Continue reading “Melinta’s Chapter 11 Auction Draws No Bids, Deerfield to Get Assets”

Amunix Raises $73M to Bring Safer T Cell Engagers to Solid Tumors

Cell therapies have helped treat some blood cancers, but toxic side effects are one limitation preventing their use in solid tumors. Amunix has, since its 2006 launch, licensed to biopharmas technology developed by company co-founder Volker Schellenberger to extend the half-life of some drugs while avoiding triggering an unwanted immune response. Now that technology has … Continue reading “Amunix Raises $73M to Bring Safer T Cell Engagers to Solid Tumors”

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data. The results of potentially hundreds of clinical trials of approved drugs and medical devices will have to be published on the ClinicalTrials.gov website in the … Continue reading “Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov”

Novartis Leads $100M Round for Fibrosis-Focused Pliant Therapeutics

When Novartis signed on as a partner to Pliant Therapeutics last fall, it also agreed to eventually take an equity stake in the smaller biotech. The Swiss pharmaceutical giant made good on that commitment Tuesday, leading a $100 million investment. Besides Novartis, the Series C round of funding adds so-called crossover investors, firms that invest … Continue reading “Novartis Leads $100M Round for Fibrosis-Focused Pliant Therapeutics”

Sanofi Wins FDA Nod for Combo Therapy in Multiple Myeloma

The FDA on Monday approved a Sanofi antibody drug for adults with multiple myeloma whose disease hasn’t responded to at least two prior therapies, including the chemotherapy lenalidomide and a proteasome inhibitor. The drug, isatuximab-irfc (Sarclisa), was OK’d for patients in combination with pomalidomide, a chemotherapy, and dexamethasone, a corticosteroid (pom-dex). The Sanofi (NYSE: [[ticker:SNY]]) … Continue reading “Sanofi Wins FDA Nod for Combo Therapy in Multiple Myeloma”

Gilead Boosts Cancer Drug Pipeline With $4.9B Deal for Forty Seven

Gilead Sciences, which finished 2019 with nearly $26 billion at its disposal, is putting some of that money to work with a $4.9 billion deal to acquire cancer immunotherapy developer Forty Seven. Under deal terms announced Monday, Foster City, CA-based Gilead (NASDAQ: [[ticker:GILD]]) will pay $95.50 for each share of Forty Seven (NASDAQ: [[ticker:FTSV]]). That’s … Continue reading “Gilead Boosts Cancer Drug Pipeline With $4.9B Deal for Forty Seven”

ORIC Pharma Plans IPO to Test Therapies for Drug-Resistant Cancers

With one investigational cancer drug in Phase 1 testing and a second one approaching the clinic, ORIC Pharmaceuticals is looking to tap the public markets for funds to finance that research. The company, which has set a preliminary target of about $86 million for its initial public offering, is looking to list on the Nasdaq … Continue reading “ORIC Pharma Plans IPO to Test Therapies for Drug-Resistant Cancers”

Xilio Unveils New Name, $100M to Bring Targeted Cancer Drugs to Clinic

Cancer immunotherapy’s use can be limited by its side effects throughout the body. Xilio Therapeutics is developing technology that selectively activates a therapy’s potent cancer-killing activity specifically at the tumor and it has raised $100.5 million to advance two programs to clinical testing. The financing was led by Takeda Ventures. Along with the new cash, … Continue reading “Xilio Unveils New Name, $100M to Bring Targeted Cancer Drugs to Clinic”

Biogen, Sangamo Ink Neuro Deal for New “Gene Regulation” Therapies

Biogen is opening up its checkbook again to get its hands on innovative approaches to some brain disorders that have proven especially recalcitrant to new types of treatment. The Cambridge, MA-based neuroscience drug developer is paying gene editing company Sangamo Therapeutics (NASDAQ: [[ticker:SGMO]]) $350 million up front in a collaboration on potential one-time treatments for … Continue reading “Biogen, Sangamo Ink Neuro Deal for New “Gene Regulation” Therapies”

Bio Roundup: COVID-19 Trials, Esperion’s Approvals, NASH News & More

Clinical trials have historically hewn to a rigid format. A trial is designed, conducted according to that design, and then results are analyzed. Making changes in the midst of the study was a no-no. In recent years, regulators have showed openness to clinical trial designs intended to make drug testing more efficient. We’ll get to … Continue reading “Bio Roundup: COVID-19 Trials, Esperion’s Approvals, NASH News & More”

Passage Bio’s IPO Raises $216M to Fund Gene Therapy Studies

Gene therapy developer Passage Bio priced its initial public offering at $18 per share, raising $216 million—72 percent more than it originally planned to raise. Earlier this month Passage filed to offer 7.4 million shares, but later increased that to 10 million, then 12 million, shares that sold at the high end of its $16 … Continue reading “Passage Bio’s IPO Raises $216M to Fund Gene Therapy Studies”

Biohaven’s Migraine Pill Is the Latest CGRP Drug to Win the FDA’s OK

[Updated 2/28/2020, 2:45 p.m. See below.] A Biohaven Pharmaceutical migraine drug has won FDA approval, clearing the way to the market for a new treatment option for the millions of people who suffer from the debilitating condition. The Biohaven (NYSE: [[ticker:BHVN]]) drug rimegepant (Nurtec) was developed for acute migraine in adults, treating a migraine attack … Continue reading “Biohaven’s Migraine Pill Is the Latest CGRP Drug to Win the FDA’s OK”

Gilead, Moderna Candidates Ramp Up Coronavirus Drug, Vaccine Testing

An investigational antiviral drug Gilead Sciences has been developing to treat infections caused by the Ebola virus will be tested in about 1,000 adults diagnosed with COVID-19, the novel coronavirus that has infected tens of thousands of people and killed more than 2,500. On Wednesday, Foster City, CA-based Gilead (NASDAQ: [[ticker:GILD]]) announced the start of … Continue reading “Gilead, Moderna Candidates Ramp Up Coronavirus Drug, Vaccine Testing”

Esperion’s Combo Pill for Lowering Cholesterol Levels Wins FDA Nod

An Esperion Therapeutics drug that pairs two cholesterol-lowering medicines in a single pill has been approved by the FDA, the second regulatory nod for the company in less than a week. The reglator’s decision covers the combination of Esperion’s bempedoic acid (Nexletol) and ezetimibe, an older generic drug for reducing levels of the “bad” form … Continue reading “Esperion’s Combo Pill for Lowering Cholesterol Levels Wins FDA Nod”

Takeda Bases PvP Biologics Buyout on Promising Early Celiac Drug Data

About three years ago fledgling San Diego-based startup PvP Biologics announced a $35 million deal with Takeda Pharmaceutical that gave the Japan pharma giant rights to acquire the company down the line. That day is here. Takeda (NYSE: [[ticker:TAK]]) acquired the company for an undisclosed amount up front, plus up to $330 million in payments … Continue reading “Takeda Bases PvP Biologics Buyout on Promising Early Celiac Drug Data”

With Foamix Merger Weeks Away, Menlo Itching Drug Fails a Phase 2 Test

A Menlo Therapeutics drug in testing for various itching conditions has failed a Phase 2 study, but executives say the results won’t translate to its lead itching target nor will they affect its pending merger with Foamix Pharmaceuticals. The Menlo (NASDAQ: [[ticker:MNLO]]) drug, serlopitant, is an experimental treatment for pruritus, itching that’s associated with a … Continue reading “With Foamix Merger Weeks Away, Menlo Itching Drug Fails a Phase 2 Test”

Bicycle Therapeutics Lands $30M From Genentech in New Cancer R&D Pact

Genentech is the latest company to enter a drug discovery partnership with Bicycle Therapeutics, adding a new alliance in cancer research for the clinical-stage biotech. Under an agreement announced Tuesday, Roche subsidiary Genentech is paying Bicycle (NASDAQ: [[ticker:BCYC]]) $30 million up front. As programs progress, Bicycle could earn up to $1.7 billion in total milestone … Continue reading “Bicycle Therapeutics Lands $30M From Genentech in New Cancer R&D Pact”

UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System

At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced … Continue reading “UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System”

Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected

As Esperion Therapeutics steered its cholesterol-lowering drug through clinical testing and regulatory review, CEO Tim Mayleben did something unusual for a pharmaceutical executive: he spoke openly about price. Specifically, he talked about how inexpensive the drug would be. As early as two years ago, Mayleben said an FDA-approved Esperion (NASDAQ: [[ticker:ESPR]]) drug would cost patients … Continue reading “Esperion’s FDA-Approved Cholesterol Drug Priced Even Lower Than Expected”

NGM Bio’s NASH Drug Shows Promise, Shares Rise on Early Phase 2 Data

In what looks to be a transformative year for potential treatments of nonalcoholic steatohepatitis, the liver disease better known as NASH, another biotech has revealed that its experimental drug appears to improve the condition compared to a placebo. NGM Biopharmaceuticals (NASDAQ: [[ticker:NGM]]) revealed preliminary data on Monday showing that 22 percent of patients who received … Continue reading “NGM Bio’s NASH Drug Shows Promise, Shares Rise on Early Phase 2 Data”

Invetx Fetches $15M to Develop Biologic Drugs for Man’s Best Friend

Veterinarians have a saying that a cat is not a small dog, says Invetx CEO Juergen Horn. Obviously, a dog of any size isn’t the same as a human. But Horn, a veterinarian, says there are enough similarities between the species to take the science behind biological drugs for people and apply it to animals. … Continue reading “Invetx Fetches $15M to Develop Biologic Drugs for Man’s Best Friend”

Lundbeck’s Alder Bio Bet Pays Off With FDA Approval of Migraine Drug

A migraine drug that Lundbeck added to its pipeline via its nearly $2 billion acquisition of Alder BioPharmaceuticals won FDA approval on Friday. The drug, eptinezumab (Vyepti), is part of a new class of antibody therapies developed to prevent migraine attacks before they start. These drugs block calcitonin gene-related peptide (CGRP), a protein associated with … Continue reading “Lundbeck’s Alder Bio Bet Pays Off With FDA Approval of Migraine Drug”

Bio Roundup: Agile Approval, Coronavirus Collabs, Spruce’s $88M & More

The price of insulin, a life-saving treatment discovered a century ago, has been a flashpoint amid the broader drug pricing debate. The FDA is trying to tame high insulin prices by encouraging price competition. The FDA has historically regarded insulin as a drug. But insulin isn’t a chemical drug, it’s made from biological material. Under … Continue reading “Bio Roundup: Agile Approval, Coronavirus Collabs, Spruce’s $88M & More”

SeaGen Adds Five Prime Therapeutics Antibodies in Licensing Deal

Since a major restructuring at Five Prime Therapeutics in October that kicked off a wind-down of most of its research and preclinical efforts, the company has been looking to add to its partnerships portfolio. On Wednesday, South San Francisco-based Five Prime (NASDAQ: [[ticker:FPRX]]) said it inked one such new deal. The agreement, a license deal … Continue reading “SeaGen Adds Five Prime Therapeutics Antibodies in Licensing Deal”

Spruce Bio Raises $88M for Clinical Tests of Rare Endocrine Disease Drug

Spruce Biosciences has raised $88 million to advance clinical testing of a drug for a rare inherited endocrine disorder that can lead to a potentially life-threatening hormonal imbalance. San Francisco-based Spruce aims to treat a form of congenital adrenal hyperplasia (CAH), an inherited condition that leads to a deficiency in enzymes needed to produce certain … Continue reading “Spruce Bio Raises $88M for Clinical Tests of Rare Endocrine Disease Drug”

EnClear Therapies Nets $10M to Test Neuro Disease ‘Dialysis’ Device

Many companies are working to develop new drugs that target harmful proteins associated with neurodegenerative diseases. EnClear Therapies has raised a $10 million Series A round of financing from a syndicate of investors to advance a device that it says could help treat neurodegenerative diseases by filtering out such proteins from cerebral spinal fluid (CSF), … Continue reading “EnClear Therapies Nets $10M to Test Neuro Disease ‘Dialysis’ Device”

Teva Drug Fails to Beat Placebo in Pediatric Tourette Patient Trials

A Teva Pharmaceutical drug in testing as a treatment for tics in pediatric patients with moderate-to-severe Tourette syndrome has failed two late-stage trials. Israel-based Teva (NYSE: [[ticker:TEVA]]) said Wednesday that the drug, deutetrabenazine, didn’t beat a placebo in reducing motor and phonic tics—the main goals of the Phase 2/3 and Phase 3 trials. Those signs … Continue reading “Teva Drug Fails to Beat Placebo in Pediatric Tourette Patient Trials”

Endo Names Blaise Coleman Successor to Retiring CEO Paul Campanelli

Endo International’s search for retiring CEO Paul Campanelli’s successor is ending close to home. Dublin, Ireland-based Endo (NASDAQ: [[ticker:ENDP]]) announced Wednesday that Chief Financial Officer Blaise Coleman will become president and CEO starting March 6. He will also take a seat on Endo’s board of directors. Before joining Endo in 2015, Coleman held leadership roles … Continue reading “Endo Names Blaise Coleman Successor to Retiring CEO Paul Campanelli”

Xcelerating Life Sciences Boston Will Explore Biopharma’s Future in Digital Health

Join Xconomy on April 29 at Takeda Pharmaceuticals’ Boston location for the next in our Xcelerating Life Sciences event series: Biopharma’s Future in Digital Health. The half-day conference will bring together innovators, executives, rising pioneers, entrepreneurs, investors, and scientists to examine what’s fueling Boston’s biotech investment and partnership opportunities. As the nation’s largest biopharma cluster, … Continue reading “Xcelerating Life Sciences Boston Will Explore Biopharma’s Future in Digital Health”

ResTORbio Pins “Strategic Alternatives” Pitch to Parkinson’s Promise

Three months after resTORbio’s lead drug failed a pivotal test treating lung infections in the elderly, the company is now looking for someone to buy the firm or strike a deal for its technology. In a corporate update issued Wednesday, resTORbio (NASDAQ: [[ticker:TORC]]) says it has started a process to evaluate “partnerships, acquisitions, mergers, and … Continue reading “ResTORbio Pins “Strategic Alternatives” Pitch to Parkinson’s Promise”

Five Prime, Bristol Pancreatic Cancer Drug Combo Fails Phase 2 Test

A year ago Five Prime Therapeutics cut a fifth of its workforce to save money as its worked to advance its clinical-stage drugs for solid tumor cancers. On Tuesday the company (NASDAQ: [[ticker:FPRX]]) said one of those drugs, cabiralizumab, a Five Prime antibody that Bristol-Myers Squibb (NYSE: [[ticker:BMY]]) was testing in combination with its cancer immunotherapy … Continue reading “Five Prime, Bristol Pancreatic Cancer Drug Combo Fails Phase 2 Test”