Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm, the very first Alzheimer’s medication in the last two decades, which is manufactured by Biogen Pharma.

“Aduhelm is an antibody that attacks the amyloid plaque that has been found to accumulate in the brains of people who have Alzheimer’s disease,” said Dr. Jeffrey Singer to The National Desk’s Jan Jeffcoat. “The only problem is that there’s still a lot of controversy among researchers as to whether or not those plaques are responsible for dementia or are a byproduct of some sort of another inflammatory process that’s causing dementia.”

The three executives of the expert committee of FDA have resigned in protest of Aduhelm’s approval. Dr. Singer said that the FDA has an expedited system for approval of drugs which makes these medications easily accessible by patients who may not have any time to wait.

Dr. singer claims that before 1962, FDA was only obliged to verify a drug’s safety and accurate labeling, not its efficacy.

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  First T-cell treatment for a solid tumor Amtagvi approved by the FDA from Iovance
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  Biotech Firm LianBio Announces Winding Down Operations
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  In an attempt to treat liver illness, Gilead buys CymaBay for $4.3 billion
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  Unlearn Secures $50 Million in latest funding round
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  Novartis spends €2.7 billion on acquiring MorphoSys
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  AM-Pharma Begins Phase 2 Trial of Ilofotase Alfa For Renal Damage Prevention
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  Sun and Taro reach an agreement on  $348M buyout after 17 years
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  BioNTech Allocates $20 Million to WuXi for Two Preclinical Monoclonal Antibodies
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  Alcon’s Strategic Move: AR-15512 Breakthrough in Dry Eye Treatment
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  Harvard researchers find improved efficacy against retinal disease in mice
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  Successful Phase 3 Trials Propel Innovent’s Mazdutide into China’s Obesity Market
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  In phase 2 head-to-head comparison, Curevo’s shingles vaccine is equivalent to GSK’s Shingrix
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  Merck to Acquire Harpoon Therapeutics In a Deal Worth $680M
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  Novartis signs a $100 million upfront gene therapy agreement with Voyager
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  Roche buys Point-of-Care Technology Platform from LumiraDx
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  Jazz Pharmaceuticals Faces Setback in JZP150 Phase II Trial for PTSD Treatment
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  FDA approves Wainua for Rare Disease Treatment
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  AbbVie to Shell Out $8.7B to Purchase Cerevel
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  GSK returns to Hansoh and pays $185 million upfront for an additional ADC
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  Sanofi forced to abandon Lead ADC Tusamitamab Ravtansine After Phase 3 Trial Disappointment
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  Gilead Sciences Secures Exclusive Rights in $848 Million Deal with Compugen for Innovative Cancer Therapy
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  NeuroOne Grabs FDA Clearance For Ablation Tech
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  Microscopic “super bots” repair neural wound model
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  Roche’s $2.7 Billion Move into the Obesity Market Acquisition of Carmot Therapeutics
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  Lung Cancer Data from AbbVie Paves Way for Accelerated ADC Approval, Falls Below Initial Benchmark
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  In a late-stage trial, GSK’s blood cancer medication achieves its main objective
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  Amgen Expands Amazon Partnership to Seek Generative AI Solutions
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  Roivant Bids Farewell to Lupus Treatment Following Phase 2 Failure
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  AstraZeneca’s Strategic Leap into KRAS G12D with Chinese Biotech Collaboration
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  Merck to Purchase Caraway Therapeutics For Over $600M
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  Setback for Bayer as Promising Anti-Clotting Drug Trials Halted
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  Karuna Therapeutics Phase 1b Trial Results Reinforce Cardiovascular Safety of Schizophrenia Treatment KarXT
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  Lilly plans to construct a $2.5 billion manufacturing facility in Germany
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  Gilead gives Arcellx $285 million to extend agreement for BCMA cell treatment
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  FDA Expresses Doubt Over Merck’s Cough Candidate
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  New York University Study Finds Prominent Breakthrough for Pain Management; Outperforms Pain Drug
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  Pfizer’s Cost-Cutting Measures Impact UK’s Sandwich Site, Leading to Job Loss for 500 Employees
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  Novo Says Weight Loss Alone Isn’t to Thank For Wegovy’s Heart Benefits
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  Teva Secures $100M Funding to Expedite Schizophrenia Drug Development
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  Selecta and Cartesian strengthen funding for the objectives of autoimmune cell treatment in reverse merger
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  AstraZeneca Looking For Another Liver Cancer Green Light For Imfinzi
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  Vor Bio’s ADC therapy shows encouraging engraftment with reduced toxicity
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  AstraZeneca abandons phase 2 sickle cell medication and pays $185 million to rejoin the oral obesity gold rush market
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  After success with its BabySat system, Owlet gains FDA clearance for its Dream Sock
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  Izervay Demonstrates Prolonged Efficacy in GATHER2 Study Amidst Competitive Landscape
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  Atara Turns to Pierre Fabre in Huge $640M T-Cell Deal
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  Federal Court Rejects Alvogen’s Bid for FDA Approval of Bausch’s Xifaxan Version
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  Kronos trims staff by 19% for phase 1/2 solid tumor drug
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  AstraZeneca’s zibotentan granted new life in CKD trial
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  Medeor Therapeutics’ Innovative Kidney Transplant Cell Therapy Shows Promising Results
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  FDA Advisors Greenlight First CRISPR-Based Therapy with Confidence in Off-Target Tests
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  GSK’s Jemperli Meets Survival Goal in Endometrial Cancer Trial
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  Merck invests $169 million for selective PARP1 medication
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  Belgium Considers Short-Term Prohibition of Novo’s Ozempic Weight Loss Drug
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  AstraZeneca’s Self-Administered Flu Vaccine Inches Closer to FDA Green Light
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  Merck eliminates two preclinical Kelun programs to reduce its ADC pipeline
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  Roche invests $7 billion to compete with Merck in the bowel disease market
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  Siemens Healthineers & Qure.ai partnership Aims to Enhance Tuberculosis Diagnosis Using AI
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  Merck & Co. Invests Heavily in Promising Antibody-Drug Conjugates (ADCs)
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  Basilea spends $2 million to acquire clinical-stage antifungal 
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  Gilead to invest $100 million in Assembly Bio in return for all current and future programs
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  Omeros discontinues renal disease phase 3 treatment post interim review failure
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  Roche’s Spark Joins Forces with SpliceBio for Innovative Inherited Retinal Disease Solutions
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  Ultragenyx and Mereo’s Genetic Treatment Slashes Bone Fractures by almost 70%
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  Novo Nordisk’s Strategic Move to Acquire KBP Biosciences’ Promising Kidney Disease Drug
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  Roche’s Fenebrutinib Breakthrough in Multiple Sclerosis Treatment and Blood-Brain Barrier Penetration
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  $15 Million Investment to Compete in the Eczema Challenge alongside Amgen and Sanofi
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  After a 5-month hold FDA finally clears PepGen’s myotonic dystrophy therapy
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  Labcorp Unveils Breakthrough Blood Test for Alzheimer’s Diagnosis and Neurodegenerative Disease Detection
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  Merck’s Keytruda achieves overall survival goals in early lung cancer
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  Philips Launches New Platform to Improve Health Monitoring
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  FDA Rejects Alnylam’s Expanded Approval Request for RNA Drug Patisiran in Rare Heart Condition
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  BMS to acquire Mirati in a bid to diversify oncology portfolio
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  FDA Imposes Partial Clinical Hold on Innate Pharma’s Lymphoma Program Following Safety Concerns
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  Fractyl’s GLP-1 Obesity Gene Therapy Performs Well in Weight Loss For Mice
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  FDA grants authorization to Invitae DNA test to identify cancer predisposition
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  Zeiss and Boehringer Ingelheim have formed an AI-backed alliance
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  Novartis Receives Great Reviews For Iptacon Phase 3 Performance 
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  Gilead Abruptly Halts Phase 3 Leukemia Trial Following Disappointing Data
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  Roche pays Ionis $60 million for RNA-targeting Alzheimer’s and Huntington’s disease programs
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  FDA approves RYZUMVI for pharmacologically-induced mydriasis in the U.S.
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  Takeda Wagers $580M on AcuraStem’s ALS Treatments
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  Morphic’s EMERALD-1 trial for ulcerative colitis disappoints
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  60 Degrees Pharmaceuticals Halts Tafenoquine COVID-19 Trial in Response to FDA Recommendations
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  Phase 3 trial data for Astellas’s GA drug yielded positive results
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  UCB’s Psoriasis Drug Application Faces a Further FDA Delay
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  Promising BP-NELL-PEG compound may protect astronauts from rapid bone loss in space
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  CGM-connected app feature for Type 2 diabetes patients, unveiled by Abbott and WeightWatchers
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  With the trial’s success, AbbVie prepares Botox for a different aesthetic use
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  Sanofi divests 11 CNS medications to Pharmanovia in a strategic slimming-down move
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  Kroger Health Joins Hands With Performance Kitchen to Provide Medically Tailored Food
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  Blackstone’s $250 million investment in ex-Novartis assets pays off
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  BioNTech receives $90 million from CEPI partnership
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  FDA Gives Green Light to GSK’s Innovative Bone Cancer Drug, Validating Billion-Dollar Investment
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  BMS Terminates Two Mid-Stage and Four Early-Stage Clinical Initiatives
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  Scientists successfully grow part-human part-pig kidneys to solve transplant crisis
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  Arbutus Halts COVID-19 RNA Destabilization Projects After Reviewing Early Preclinical Data
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  Ahead of the seasonal spike, Pfizer and BioNTech’s Covid vaccine receives FDA greenlight
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  Moderna Forms Multi-Billion Dollar Strategic Partnership with Immatics
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  Revvity introduces advanced preclinical imaging tech for scientists to make breakthroughs
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  European Commission Approves Updated Pfizer-BioNTech Vaccine for Omicron XBB.1.5 Variant
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  BridgeBio’s acoramidis shows positive results in phase 3 trial for heart disease
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  BMS expansion into neurodegeneration space with $95 million partnership
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  FDA Warning Letter for Tablo Hemodialysis System
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  Opdivo by Bristol Myers Shows Positive Results in Phase 3 Trial for Bladder Cancer Patients
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  Europe conducting review of potential suicide risks associated with GLP-1 drugs from Novo Nordisk
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  Pfizer to Stop Development of Oral Obesity Drug Amidst Liver Safety Concerns
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  Pfizer’s Talzenna gets wider approval for prostate cancer compared to AstraZeneca and Merck
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  Novartis Secures $3.2 Billion Acquisition of Chinook to Enhance Kidney Disease Strategy
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  AstraZeneca Adds Imfinzi and Lynparza to Ovarian Cancer Treatment
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  Astellas Pharma’s Fezolinetant Trials Show Positive Results in Reducing Vasomotor Symptoms
• Editorial Team

  Amarin goes from conventional to digital marketing for its icosapent ethyl drug VASCEPA
• Editorial Team

  AstraZeneca partners with Imperial’s VaxEquity to bolster its self-amplifying RNA based drugs pipeline
• Editorial Team

  Chinese Pharma Companies Pushing for Global Reach with focus on R&D
• Editorial Team

  Takeda looks to expand vaccine business with traction in Covid-19 and dengue
• Editorial Team

  Takeda Pharmaceutical gets FDA nod for lung cancer drug Exkivity
• Editorial Team

  Purdue Pharma’s Executives to Get Massive $7M Bonus authorized by federal judge
• Editorial Team

  Empower Pharmacy inaugurates a $55m facility in Houston
• Editorial Team

  Korean firm JW Pharma gets European Patent Office approval for gout treatment
• Editorial Team

  Xeris Pharmaceuticals gets stockholder nod on Strongbridge Biopharma acquisition
• Editorial Team

  After opioid-meltdown, Mallinckrodt gets ready for company restructuring
• Editorial Team

  Pharma will produce over 12B Covid-19 vaccine doses by Dec and 24B by June
• Editorial Team

  McKinsey’s Aamir Malik to join Pfizer as chief business innovation officer with focus on business growth and pipeline
• Editorial Team

  Hetero gets approval to make Roche’s tocilizumab in India under the brand name Tocira
• Editorial Team

  Japan investigating if Moderna vaccine contamination caused death of three people
• Editorial Team

  Court extends BMS and Pfizer exclusivity over blockbuster Eliquis patent until 2028
• Editorial Team

  Ascendis gets FDA nod on once a week pediatric growth hormone deficiency injection
• Editorial Team

  Warren Buffett pulls out of Biogen but bets on Organon
• Editorial Team

  BioAgilytix snaps MicroConstants to further build contract research services
• Editorial Team

  Paratek gets FDA’s orphan drug designation for NUZYRA for treating infections caused by Nontuberculous Mycobacteria
• Editorial Team

  Pfizer signs agreement to acquire Trillium Therapeutics for $2.26B
• Editorial Team

  Azurity acquires Arbor Pharmaceuticals to form an integrated entity
• Editorial Team

  Coherus to move beyond biosimilars with a cancer immunotherapy drug
• Editorial Team

  Pfizer and Flynn Pharma face charges in UK for unfair price hike of epilepsy drug
• Editorial Team

  China based Lynk Pharma raises $50M in series B funding round
• Editorial Team

  FDA rejects AstraZeneca and FibroGen’s roxadustat NDA for CKD related anemia
• Editorial Team

  Roche’s Actemra may see high demand and short supply due to COVID delta variant
• Editorial Team

  Sanofi acquires Translate Bio for $3.2B with renewed push on mRNA technology
• Editorial Team

  GW Pharmaceuticals gets MHRA approval for Epidiolex to treat TSC related seizures
• Editorial Team

  Celltrion gets Canadian priority review for Covid-19 antibody treatment, Regdanvimab
• Editorial Team

  Covid-19 booster shot roll out plan expected to be finalized by FDA by end of Q3
• Editorial Team

  Softbank now has $5B stake in Roche for its ability to develop drugs using data
• Editorial Team

  Bayer relying on Kerendia to drive pharma business growth with five kidney indications in sight
• Editorial Team

  Covid-19 pandemic is helping push sales of Novo Nordisk’s weight-loss drug
• Editorial Team

  Bayer to acquire Vividion Therapeutics for over $2B to boost its drugs pipeline
• Editorial Team

  Regeneron is market winner in COVID-19 antibodies with $2.6B sales
• Editorial Team

  Astellas and Minovia partner to develop treatments for mitochondrial cell therapies
• Editorial Team

  Advanz Pharma to pay $140M fine in UK for price hikes on its thyroid drug
• Editorial Team

  Enyo Pharma’s liver disease drus Vonafexor meets its phase 2a clinical study goals
• Editorial Team

  Roche relying on Polivy’s $2B potential to weather biosimilar storm
• Editorial Team

  Amgen to buy Teneobio for $2.5B to further its antibody interests
• Editorial Team

  Pfizer to cough up $345 million to resolve lawsuits over EpiPen price hikes.
• Editorial Team

  BMS’s Opdivo and Yervoy fail to show efficacy and safety in squamous head and neck cancer
• Editorial Team

  GSK gets EU order for its investigational monoclonal COVID-19 antibody therapy
• Editorial Team

  NRx Pharma’s ZYESAMI™ approved for emergency use Covid critical care in Georgia
• Editorial Team

  Kintor and Fosun sign licensing agreement to market Covid-19 drug in India and 28 African nations
• Editorial Team

  FDA adds Guillain-Barre syndrome warning to Johnson & Johnson Covid-19 vaccine
• Editorial Team

  Is Biogen’s Alzheimer’s drug worth $56K? Experts say $8400 and raise questions about efficacy
• Editorial Team

  AstraZeneca and FibroGen hit FDA committee’s safety data firewall for roxadustat
• Editorial Team

  NRx Pharmaceuticals signs deal for clinical trials of Israel’s homegrown Covid-19 vaccine
• Editorial Team

  Pharma manufacturers lawsuits against payers and benefit managers preferred drugs are on FTC’s radar
• Editorial Team

  Roche to lay off 300 to 400 employees in product development jobs
• Editorial Team

  Activist investor Elliott Management asks for new board and CEO to reapply
• Editorial Team

  Centrient Pharmaceuticals doubles its statin production capacity with a new manufacturing facility
• Editorial Team

  Tetra Bio-Pharma’s ARDS-003 combined with antiviral drugs significantly reduces viral replication
• Editorial Team

  Arrowhead and Horizon sign $700M collaboration deal to to Develop RNAi drug for uncontrolled gout
• Editorial Team

  Cusatuzumab back in Argenx’s court as Janssen’s Cilag discontinues partnership
• Editorial Team

  Verona Pharma signs $219 million deal with Nuance Pharma to market Ensifentrine in greater China
• Editorial Team

  In migraine drug battle, Eli Lilly to be sued by Teva after securing patents for Ajovy.
• Editorial Team

  Camber Pharmaceuticals to bring generic Toprol XL to the market
• Editorial Team

  Eton Pharma gets FDA nod on Rezipres® for treatment of hypotension in anesthesia settings
• Editorial Team

  Vertex scores FDA nod for kids’ cystic fibrosis drug Trikafta
• Editorial Team

  Clinical-stage Pieris Pharma signs agreement with Genentech for respiratory and ophthalmology therapies
• Editorial Team

  Bristol Myers Squibb’s multiple sclerosis drug Zeposia gets FDA approval for ulcerative colitis
• Editorial Team

  Novo Nordisk resubmits Ozempic for FDA review with new dosing regimen
• Editorial Team

  Amgen’s KRAS drug gets early FDA approval for lung cancer with specific mutation
• Editorial Team

  Myovant Sciences and Pfizer get the FDA nod on MYFEMBREE® to treat heavy menstrual bleeding with once a day treatment
• Editorial Team

  Roche is the biggest R&D spender investing 23.8% of its total sales
• Editorial Team

  NiKang Therapeutics raises $200m in Series C funding for new small molecules in oncology
• Editorial Team

  With the best pipeline in the industry, Lilly’s stock and valuation soar in 2021
• Editorial Team

  Third antibody treatment for early COVID infection approved by the FDA
• Editorial Team

  Singapore based Engine Biosciences raises $43M to grow its digital drug discovery
• Editorial Team

  Bristol-Myers Squibb and Agenus enter a $1.56bn definitive agreement to support cancer programme
• Editorial Team

  Novartis subsidiary Sandoz increasing its antibiotics manufacturing capacity in Europe with $183m investment
• Editorial Team

  Aerpio Pharmaceuticals and Aadi Bioscience merge with continued focus on advancing Fyarrotm
• Editorial Team

  Japan’s MHLW approves AstraZeneca and Moderna Covid-19 vaccines
• Editorial Team

  Janssen files for Covid19 vaccine approval in Japan
• Editorial Team

  With future in sight, GSK sells it stake in respiratory drug firm Innoviva
• Editorial Team

  HBC enters a global innovation alliance with Catalent to develop delayed-release softgel capsules
• Editorial Team

  Incyte agrees to pay $12.6M to settle kickback allegations
• Editorial Team

  Sanofi accused of widespread employee email deletion tied to its 2019 recall of Zantac
• Editorial Team

  Cerecor’s Covid-19 antibody treatment will get fast-track treatment from FDA
• Editorial Team

  Japan-based Nipro Pharma Packaging acquires Croatian manufacturer Piramida
• Editorial Team

  Most life sciences executives say digital delivery of drugs is the future of health
• Editorial Team

  Democrats demand US pharmaceutical companies on their plan to share vaccine IP as pandemic wreaks havoc in India
• Editorial Team

  Pfizer looks to build on its infectious disease expertise with Amplyx acquisition
• Editorial Team

  Potentially tough road for BMS as immuno-oncology pricing war looms
• Editorial Team

  Israel is examining Covid-19 vaccine related cases of myocarditis