Jonathan Gardner

280 articles by Jonathan Gardner

• Spark, chasing BioMarin, plans 2021 start for key hemophilia gene therapy study

  July 13, 2020

• FDA documents reveal doubts about GSK blood cancer drug

  July 10, 2020

• 5 FDA approval decisions to watch in the 3rd quarter

  July 8, 2020

• US buys up early supply of Regeneron's COVID-19 antibody cocktail

  July 7, 2020

• Regeneron advances COVID-19 antibody cocktail into late-stage trials

  July 6, 2020

• Federal coronavirus contracts dodge pricing oversight, advocacy group says

  July 1, 2020

• Without data, Inovio says study shows positive results for coronavirus vaccine

  June 30, 2020

• Former BARDA director claims HHS leaders tried to 'thwart' him in new role

  June 26, 2020

• Price for Gilead's COVID-19 drug should shrink if cheap steroid widely used, ICER says

  June 24, 2020

• By $4M, La Jolla outbids Melinta for struggling Tetraphase

  June 24, 2020

• Gilead, in latest cancer bet, puts $275M into immunotherapy startup Pionyr

  June 23, 2020

• Vaccines can end the coronavirus pandemic. Will every country get them?

  June 23, 2020

• NIH ends key COVID-19 studies of hydroxychloroquine

  June 22, 2020

• UniQure gets out the gate first in race for Huntington's gene therapy

  June 19, 2020

• With new proposal, Trump administration tries to encourage 'value-based' drug deals

  June 18, 2020

• Cheap steroid lowers risk of death in hospitalized COVID-19 patients, U.K. study finds

  June 16, 2020

• CureVac gets German backing for coronavirus vaccine, but says it's independent

  June 15, 2020

• AstraZeneca spinout wins first FDA approval 2 years after launch

  June 12, 2020

• Pressure on generic drugmakers increases with new price fixing lawsuit

  June 10, 2020

• Drug regulators in agreement on coronavirus vaccine trials, FDA official says

  June 9, 2020

• China's Innovent buys rights to Roche cancer technology

  June 9, 2020

• Alnylam details data for kidney disease drug under FDA review

  June 8, 2020

• AstraZeneca reaches deals with health charities to supply coronavirus vaccine worldwide

  June 4, 2020

• Hydroxychloroquine offers no COVID-19 protection after exposure, study shows

  June 3, 2020

• COVID-19 studies of malaria, blood pressure pills come under scrutiny

  June 3, 2020

• Bristol Myers follows Zeposia launch with positive data from key study

  June 2, 2020

• Regeneron expands Intellia gene editing deal as its post-Sanofi future emerges

  June 1, 2020

• AstraZeneca bid to expand lung cancer drug's use boosted by trial data

  May 28, 2020

• Novartis teams with Mass. Eye & Ear to join coronavirus vaccine chase

  May 28, 2020

• With $11B stock sale, Sanofi loosens ties with Regeneron

  May 26, 2020

• Intercept shares fall as FDA again delays closely watched NASH drug

  May 22, 2020

• Bangladesh pharma claims to be first to launch generic remdesivir

  May 21, 2020

• More questions than answers as Moderna's coronavirus vaccine speeds ahead

  May 19, 2020

• Ousted BARDA director: Hydroxychloroquine push distracted government scientists

  May 14, 2020

• J&J myeloma data heat up cell therapy battle

  May 13, 2020

• Activist investor pushes Alexion to sell after Portola deal

  May 12, 2020

• Dyno spins out of Harvard's laboratories with an aim to make gene therapy better

  May 11, 2020

• Novartis wins approval for niche lung cancer drug

  May 7, 2020

• After donation to the U.S., Gilead outlines plans to distribute COVID-19 drug worldwide

  May 6, 2020

• Pfizer, BioNTech launch U.S. trial of coronavirus vaccine

  May 5, 2020

• A coronavirus vaccine may arrive next year. 'Herd immunity' will take longer.

  May 4, 2020

• Texas university spins out Taysha, a gene therapy startup with 15 programs

  April 29, 2020

• Pfizer resumes trial recruitment suspended by coronavirus

  April 28, 2020

• Repurposed arthritis drug disappoints in closely watched COVID-19 trial

  April 27, 2020

• Malaria drug's potential against coronavirus dims as data mounts

  April 22, 2020

• Trial data help small biotech ready its anti-itch drug for approval

  April 21, 2020

• Positive data keep Bristol Myers and Exelixis in the kidney cancer race

  April 20, 2020

• Vir reminds biopharma its original aim is hepatitis B

  April 16, 2020

• J&J cuts sales forecast by $7B as coronavirus impact hits

  April 14, 2020

• AstraZeneca and Merck drug wins approval for rare cancer after failing elsewhere

  April 13, 2020

• Eye drug side effects are real, Novartis confirms in new warning

  April 9, 2020

• Myokardia at inflection point as heart drug readout nears

  April 9, 2020

• FDA delays decision on Roche spinal muscular atrophy drug

  April 7, 2020

• GSK bets $250M on Vir's antibody approach to treating coronavirus

  April 6, 2020

• Contamination concerns spur FDA call for nationwide withdrawal of heartburn drug

  April 1, 2020

• Under pressure, FDA touts speedy coronavirus drug development

  April 1, 2020

• Drugmakers await reckoning as doctors, patients make tough choices during pandemic

  April 1, 2020

• With latest FDA submission, Bristol Myers keeps pace with Celgene milestones

  March 31, 2020

• Merck's search for growth outside Keytruda may not end in heart disease

  March 30, 2020

• Sanofi adds mRNA to coronavirus vaccine push

  March 27, 2020

• Bristol Myers investors breathe easier as multiple sclerosis drug approved by FDA

  March 26, 2020

• In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug

  March 25, 2020

• Leukemia drug from Roche, AbbVie extends survival, study finds

  March 23, 2020

• Remdesivir, chloroquine move to forefront as White House tries to speed coronavirus response

  March 19, 2020

• No White House offer for coronavirus vaccine access, CureVac says

  March 17, 2020

• Big pharma shied away from gene therapy for years. Academia picked up the slack

  March 17, 2020

• Regeneron and Sanofi speed Kevzara into coronavirus trials

  March 16, 2020

• New sickle cell drugs priced too high, ICER says

  March 13, 2020

• AstraZeneca and Merck's string of Lynparza successes ends in ovarian cancer

  March 12, 2020

• Coronavirus spread prompts FDA to postpone nearly all overseas inspections

  March 10, 2020

• Gates, Wellcome hatch $125M plan to speed coronavirus treatments

  March 10, 2020

• FDA, FTC put drugmakers on notice about tactics to block biosimilars

  March 9, 2020

• AstraZeneca immunotherapy combination falls short in bladder cancer trial

  March 6, 2020

• Federal prosecutors make another claim against Mallinckrodt over Acthar prices

  March 4, 2020

• New estimate puts cost to develop a new drug at $1B, adding to long-running debate

  March 3, 2020

• Sangamo sees vindication in Biogen gene-editing deal

  Feb. 28, 2020

• Takeda's small celiac disease bet turns into acquisition

  Feb. 26, 2020

• Mallinckrodt offers $1.6B in deal to settle opioid claims

  Feb. 25, 2020

• In a nod toward pharma, ICER makes deal to access real-world evidence

  Feb. 24, 2020

• Coronavirus weighs on AstraZeneca's China expansion

  Feb. 14, 2020

• Merck builds case for Keytruda use in breast cancer

  Feb. 12, 2020

• Exelixis prostate cancer data could help stave off competitive threats

  Feb. 11, 2020

• In Alzheimer's, a plan to treat patients earlier doesn't work out for Lilly, Roche

  Feb. 10, 2020

• Nestlé boosts investment as Aimmune preps launch of peanut allergy drug

  Feb. 5, 2020

• January price increases confirm slowing drug inflation

  Feb. 4, 2020

• US cancels trial after finding vaccine doesn't prevent HIV

  Feb. 3, 2020

• FDA approves Aimmune drug as first treatment for peanut allergy

  Jan. 31, 2020

• Amgen, Pfizer biosimilar sales pressure top drugs

  Jan. 31, 2020

• Preventive Alzheimer's trial data due within weeks, Lilly says

  Jan. 30, 2020

• Decibel CEO steps down as company pares workforce

  Jan. 29, 2020

• Pfizer lays out gene therapy aspirations

  Jan. 28, 2020

• To close merger, AbbVie and Allergan sell digestive drug to AstraZeneca

  Jan. 27, 2020

• FDA decision nears on Aimmune's contested peanut allergy drug

  Jan. 24, 2020

• Roche strengthens case for SMA drug with new study data

  Jan. 23, 2020

• Safety risks highlighted in FDA letter on Sarepta's Vyondys

  Jan. 22, 2020

• BeiGene cancer drug data sets up China duel with Merck

  Jan. 21, 2020

• Lilly seeking out more 'Dermira-like' deals: report

  Jan. 17, 2020

• Civica advances drug supply strategy with Thermo Fisher deal

  Jan. 16, 2020

• Astellas swoops in for Adaptimmune deal a day after positive data

  Jan. 14, 2020

• Biogen finds $75M home for Pfizer Alzheimer's drug

  Jan. 13, 2020

• Ultragenyx boosted by trial data for 2nd gene therapy

  Jan. 10, 2020

• 5 trends to watch at the FDA in 2020

  Jan. 9, 2020

• Solid cuts one-third of staff, goes all in on delayed gene therapy

  Jan. 9, 2020

• AbbVie to house Allergan Botox business in separate unit

  Jan. 8, 2020

• Merck's Keytruda falls short of rivals in 1 lung cancer type

  Jan. 7, 2020

• Merck adds to lung cancer wall with Otsuka deal

  Jan. 6, 2020

• Wave's Huntington's drug shows effect but falls short of mark set by Roche and Ionis

  Jan. 2, 2020

• AstraZeneca and Merck's Lynparza cleared by FDA for pancreatic cancer

  Dec. 30, 2019

• Roche hands $1B to Sarepta in major return to gene therapy deals

  Dec. 23, 2019

• Daiichi, AstraZeneca breast cancer drug joins bumper crop of early FDA approvals

  Dec. 20, 2019

• AstraZeneca lupus drug shows potential, but it may not be enough for FDA

  Dec. 19, 2019

• Muscle data doesn't help Solid build faith in its gene therapy

  Dec. 18, 2019

• BeiGene's Brukinsa bet falls short against Imbruvica

  Dec. 16, 2019

• Wave cancels its Exondys competitor and heads back to the lab in muscular dystrophy

  Dec. 16, 2019

• In stunning twist, FDA approves Sarepta's Duchenne drug it rejected

  Dec. 12, 2019

• House passes drug pricing bill that pharma warned would bring 'nuclear winter'

  Dec. 12, 2019

• Value-based pricing for gene therapy? Maybe not ready for hemophilia

  Dec. 11, 2019

• UniQure, Pfizer updates hint at gene therapy potential in hemophilia B

  Dec. 10, 2019

• Leukemia rivals try to stay ahead as Merck, Lilly chase

  Dec. 10, 2019

• As CAR-T presses ahead in multiple myeloma, alternative approaches gain supporters

  Dec. 9, 2019

• Disruptor of the Year: The Federal Trade Commission

  Dec. 9, 2019

• Pharma of the Year: AstraZeneca

  Dec. 9, 2019

• We're not for sale, Alexion executives declare

  Dec. 6, 2019

• Cancer gene therapy backed by Blackstone gets trial win

  Dec. 5, 2019

• New approval for Roche's Tecentriq heats up lung cancer battle with Keytruda

  Dec. 4, 2019

• Will sky-high drug prices spur the US to use an obscure power over patents?

  Dec. 4, 2019

• Opioid makers subject of US grand jury probe

  Nov. 27, 2019

• Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo

  Nov. 25, 2019

• What Novartis needs to do to make Medicines Co. deal a success

  Nov. 25, 2019

• Calquence OK boosts AstraZeneca's challenge to Imbruvica

  Nov. 22, 2019

• FDA's rapid review pace nets an early approval for Alnylam's second drug

  Nov. 20, 2019

• France clears way for wide use of Vertex's Orkambi

  Nov. 20, 2019

• Alkermes follows up restructuring with Rodin acqusition

  Nov. 18, 2019

• Novartis sickle cell drug wins FDA approval

  Nov. 15, 2019

• BeiGene FDA cancer drug nod seen as breakthrough for Chinese biopharma

  Nov. 15, 2019

• Sarepta brings in more gene therapies with StrideBio deal

  Nov. 14, 2019

• ICER draws new gene therapy pricing framework

  Nov. 13, 2019

• Solid gene therapy trial halted again by FDA

  Nov. 12, 2019

• Roche's oral SMA drug scores in older patients

  Nov. 11, 2019

• Fibrogen, AstraZeneca confirm roxadustat's heart safety months after confusing first readout

  Nov. 8, 2019

• Sarepta tries softer approach to resolve FDA setback

  Nov. 8, 2019

• Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout

  Nov. 7, 2019

• AstraZeneca's China ambitions grow with new R&D investments

  Nov. 6, 2019

• Third Neulasta biosimilar on its way as Sandoz wins long-delayed FDA approval

  Nov. 5, 2019

• Halozyme laying off 160 after pancreatic cancer trial comes up short

  Nov. 4, 2019

• Amgen's China ambitions become clear with BeiGene deal

  Nov. 1, 2019

• Sanofi pays $315 million to settle Lemtrada go-slow claims

  Oct. 31, 2019

• Novartis gene therapy ambitions dealt another blow by FDA hold on Zolgensma

  Oct. 30, 2019

• AstraZeneca joins Bristol-Myers' run at Merck in lung cancer

  Oct. 28, 2019

• Allergan pays $750M to rid itself of Namenda antitrust charges

  Oct. 28, 2019

• AstraZeneca blood cancer drug heading for showdown with AbbVie's

  Oct. 24, 2019

• Longtime Lilly diabetes chief Conterno to step down

  Oct. 23, 2019

• 7 questions on Biogen's revival of a failed Alzheimer's drug

  Oct. 22, 2019

• Teva offers $23B of Suboxone to get out of opioid litigation

  Oct. 21, 2019

• Drug distributors, Teva settle in Ohio opioid case

  Oct. 21, 2019

• Merck's Ebola vaccine wins key European vote

  Oct. 18, 2019

• Give up board chairmanship? No thanks, US big pharma CEOs say

  Oct. 16, 2019

• Lilly shuttering UK neuroscience research site

  Oct. 15, 2019

• Pelosi drug plan would save $370B, but could reduce R&D, forecasters say

  Oct. 14, 2019

• On second thought, AbbVie's new arthritis drug not so costly, ICER says

  Oct. 11, 2019

• ProQR eye-disease data lend confidence that pivotal trial will succeed

  Oct. 10, 2019

• Feeling pressure in hemophilia, Novo signs gene editing deal with Bluebird

  Oct. 9, 2019

• Akcea inks deal with Pfizer, rebounding after leadership shuffle

  Oct. 7, 2019

• Sarepta, in shadow of FDA setback, marks gene therapy progress

  Oct. 4, 2019

• Amicus rare disease data build hope for approval

  Oct. 2, 2019

• FDA knocks back AstraZeneca's respiratory ambitions

  Oct. 1, 2019

• AstraZeneca, Merck strengthen lead in PARP drug class

  Sept. 28, 2019

• Medicines Co. gets cholesterol confirmation

  Sept. 25, 2019

• Clovis shares plunge after downgrade raises questions on path forward

  Sept. 24, 2019

• Amag fights activist investor's bid for board seats

  Sept. 23, 2019

• Is the future of diabetes treatment better drugs or better care?

  Sept. 23, 2019

• Novo gains approval for first oral diabetes drug of its kind

  Sept. 20, 2019

• The top drugs facing cuts under Pelosi's pricing plan

  Sept. 20, 2019

• House Democrats forge ahead with direct Medicare drug price negotiation

  Sept. 19, 2019

• Acceleron dealt pipeline setback

  Sept. 17, 2019

• 5 questions ESMO cancer drug data might answer

  Sept. 16, 2019

• Another BACE dropped as Biogen and Eisai halt elenbecestat trials

  Sept. 13, 2019

• Adverum sinks on first gene therapy data for eye disease

  Sept. 12, 2019

• ICER dings Novo's new oral diabetes drug

  Sept. 11, 2019

• Medicare would negotiate prices for 250 drugs under House Democrats' plan

  Sept. 10, 2019

• Trial win could drive Acadia's Nuplazid to new use

  Sept. 9, 2019

• Roivant offloads biotech stakes in $3B alliance with Japanese pharma

  Sept. 6, 2019

• Novo Nordisk Foundation makes green grant to Danish-US university collaboration

  Sept. 5, 2019

• Ultragenyx gene therapy data disappoints investors

  Sept. 5, 2019

• Medicines Co.'s cholesterol drug looks good to take on PCSK9 rivals

  Sept. 2, 2019

• Novartis vies for multiple sclerosis dominance with Arzerra trial

  Aug. 30, 2019

• AstraZeneca gets lupus win but past failure could slow progress

  Aug. 29, 2019

• Amyloid's last hope? Prevention studies next big test for Alzheimer's research

  Aug. 29, 2019

• Immatics shows Celgene isn't done stocking cell therapy pipeline

  Aug. 28, 2019

• Gene editing companies oppose altering of embryos

  Aug. 27, 2019

• To patients, Sarepta repeats message on surprise rejection of Duchenne drug

  Aug. 22, 2019

• Sarepta now needs flawless progress for gene therapy

  Aug. 20, 2019

• Sarepta Duchenne drug rejected by FDA in surprise setback

  Aug. 19, 2019

• Pharming deal shows there's still life in struggling cancer drug class

  Aug. 15, 2019

• Regeneron gets cholesterol drug win where Praluent won't go

  Aug. 14, 2019

• Deciphera success sets up 2-horse race in gastrointestinal cancer

  Aug. 13, 2019

• AstraZeneca cancer drugs build as primary care shrinks

  Aug. 12, 2019

• Nektar battered over manufacturing issues and Bristol-Myers pullback

  Aug. 9, 2019

• Hospitalized gene therapy patient triggers Sarepta sell off

  Aug. 8, 2019

• Lilly shuffles executives overseeing oncology and M&A

  Aug. 7, 2019

• Teva finance chief resigns in midst of restructuring

  Aug. 7, 2019

• Amneal founders take reins as business struggles mount

  Aug. 5, 2019

• Sickle-cell setback triggers share slide at GlycoMimetics

  Aug. 5, 2019

• Takeda board lays out Shire integration goals

  Aug. 2, 2019

• Medicines Co. awaits its date with destiny

  Aug. 1, 2019

• White House backs importing drugs from abroad

  July 31, 2019

• How Mylan ended as a junior partner in its Pfizer deal

  July 30, 2019

• Mylan's tumble ends with Pfizer rescue

  July 29, 2019

• Senate advances drug pricing bill, setting up September vote

  July 26, 2019

• Roche highlights growth ahead of US biosimilar storm

  July 25, 2019

• Senate committee targets drug price increases with broad bill

  July 23, 2019

• Nonprofit US generics company secures supplier in Hikma

  July 23, 2019

• Opioid and price fixing legal liabilities mount for generic companies

  July 22, 2019

• Ultragenyx close to learning whether gene therapy gamble will pay off

  July 19, 2019

• MyoKardia cuts all ties to Sanofi

  July 18, 2019

• Merck urges caution on use of its newly approved antibacterial

  July 17, 2019

• Advocacy group pledges six-figure ad buy to support Trump drug price plan

  July 17, 2019

• Xarelto falls into the donut hole

  July 16, 2019

• AbbVie bets on early immuno-oncology asset

  July 15, 2019

• Amgen and Novartis halt Alzheimer's studies as faith in amyloid hypothesis dims

  July 12, 2019

• Billion-dollar settlement gets Reckitt out of federal opioid probes

  July 11, 2019

• In win for pharma, Trump TV drug price rule struck down

  July 9, 2019

• Roche acknowledges the obvious, extends Spark buyout deadline

  July 8, 2019

• Array pushed Pfizer for a higher price to get deal done

  July 1, 2019

• Pfizer muscular dystrophy gene therapy stumbles on safety

  June 28, 2019

• Zogenix boosted on FDA about-face for seizure drug application

  June 27, 2019

• AstraZeneca gets immuno-oncology win in a disease that Merck doesn't rule

  June 27, 2019

• AbbVie deal for Allergan not about the taxes, thanks to 2017 law

  June 26, 2019

• Novartis fights off generics courtroom challenge

  June 25, 2019

• Bristol-Myers price for Celgene now includes Otezla sell-off

  June 24, 2019

• Beating Keytruda a big task, Exelixis and Roche find

  June 21, 2019

• Sanofi to cut 466 workers in Europe as it seeks to refocus R&D

  June 20, 2019

• Pfizer goes big on targeted cancer therapies with $11.4B Array buy

  June 17, 2019

• Upadacitinib a plus for AbbVie in rheumatoid arthritis, doc survey says

  June 14, 2019

• Bluebird sets $1.8M price tag for blood-disease gene therapy

  June 14, 2019

• Savara lung disease trial misses, but execs vow to press on

  June 13, 2019

• FTC demands could mean months-long delay for Roche-Spark deal

  June 12, 2019

• Novo Nordisk goes for broke on semaglutide heart data

  June 11, 2019

• Trulicity heart data falls short for Lilly investors

  June 10, 2019

• Amicus widens UPenn gene therapy collaboration

  May 29, 2019

• BioMarin readies hemophilia gene therapy for FDA submission

  May 28, 2019

• Pay-for-delay deals disappearing, FTC says

  May 24, 2019

• Could Novartis' gene therapy have more than one price?

  May 23, 2019

• 5 novel immuno-oncology targets to know before ASCO

  May 22, 2019

• No news is bad news for Tocagen

  May 22, 2019

• Array gets a win in colorectal cancer

  May 21, 2019

• Long-term heart data reassures for Medicines Co.

  May 20, 2019

• Medicare decides against tighter management of HIV drugs

  May 17, 2019

• Breast cancer survival data buoys Macrogenics and Puma

  May 16, 2019

• Cost-effectiveness agency clears Biogen's Spinraza for UK patients

  May 15, 2019

• Solid's gene therapy stumble makes Sarepta's lead clearer

  May 14, 2019

• Generics price-fixing lawsuit focuses on Teva's role as catalyst

  May 13, 2019

• Fibrogen confuses as it tries to explain blood-boosting drug data

  May 10, 2019

• Biopharma happily takes the tax cuts, but the jobs are harder to find

  May 9, 2019

• AstraZeneca's share dilution gamble on Daiichi drug pays off

  May 8, 2019

• Roche risdiplam data heats up SMA rivalry with Novartis

  May 7, 2019

• Novartis makes final Zolgensma pitch before FDA decision

  May 6, 2019

• Approval of $225,000-a-year tafamidis comes early for Pfizer

  May 6, 2019

• Rebate ban not a magic balm, federal budget forecasters say

  May 3, 2019

• Cost cuts to the rescue for Teva, so far

  May 2, 2019

• Generic Advair hits GSK revenues hard

  May 1, 2019

• Pfizer prospects for tafamidis market

  April 30, 2019

• Alexion, AstraZeneca secure backing of EMA panel for key drugs

  April 29, 2019

• Roche's takeout of Spark not working like a Swiss watch

  April 26, 2019

• Don't worry about Humira biosimilars, the pipeline will deliver, AbbVie says

  April 25, 2019

• Medicare proposes raising CAR-T pay, but reimbursement solution years away

  April 24, 2019

• Competition and donut hole discount takes toll on Xarelto sales

  April 23, 2019

• Safety setback for Pfizer, Lilly pain drug should have Regeneron and Teva feeling nervous

  April 22, 2019

• $300M loan boosts launch of TherapeuticsMD hot flash pill

  April 18, 2019

• Sarepta may have seen off another rival in Wave

  April 17, 2019

• Its ambitions restrained, Amgen sets modest Evenity price

  April 16, 2019

• Kidney data may give J&J diabetes drug an edge

  April 15, 2019

• Gilead and Novo Nordisk pair up to take on NASH

  April 12, 2019

• Intercept sputters as it reveals full Ocaliva NASH data to doctors

  April 11, 2019

• Indivior draws criminal indictment for opioid marketing practices

  April 10, 2019

• Pharmacy's 'middlemen' counter pharma's campaign to shift the price blame

  April 9, 2019

• Audentes lays down marker in muscular dystrophy

  April 8, 2019

• Copay assistance snares 3 drug companies in Medicare kickback charges

  April 5, 2019

• What to look for after Zolgensma's launch

  April 4, 2019

• Roche must ask Spark shareholders once again to sell

  April 3, 2019