The approval follows P-III trials (PROMISE-1 in episodic migraine & PROMISE-2 in chronic migraine) assessing Vyepti vs PBO in 2,076 adult patients for the preventive treatment of migraine who have at least 4 migraine days/mos.
The studies met its 1EPs of decrease in mean monthly migraine days (MMD) over 1-12wks and showed 50% & 75% responder rates & good tolerability
Vyepti is a humanized mAb that binds to calcitonin gene-related peptide (CGRP)
Click here to read full press release/ article | Ref: PRNewswire | Image: BT
The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery)
Result of FeDeriCa Study: The GMR for the 1EPs (1.22) with the lower limit (90%) CI of the GMR (1.14≥0.80). 2EPs of non-inferior levels of Herceptin was also met with blood conc. GMR (1.33) with the lower limit (90%)
Phesgo combines the same mAb as Perjeta and Herceptin with Halozyme Therapeutics Enhanze drug delivery technology in a novel formulation for SC use
Click here to read full press release/ article | Ref: Roche | Image: Fierce Biotech
The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT)
Result: The 1EPs of sCR rate post-transplant was significantly higher (29 % vs. 20 %); median follow-up (18.8 mos.); reduction in the risk of disease progression or death (53%)
Darzalex is the first CD38-directed mAb approved to treat multiple myeloma. The subcutaneous formulation was approved by Health Canada to treat patients with multiple myeloma in 2020
Click here to read full press release/ article | Ref: Newswire.CA | Image: Philadelphia Inquirer
In a recent interview with PharmaShots, William F. Doyle, Executive Chairman at Novocure shared information about the company’s activities in the field of glioblastoma and mesothelioma. He also discussed the company’s technology, Tumor Treating Fields (TTFields), and its potential for broad applicability across solid tumors.
Novocure is a global oncology company working to extend survival in aggressive forms of cancer through the development & commercialization of our innovative therapy, Tumor Treating Fields, also known as TTFields
TTFields are low-intensity, wave-like electric fields. These invisible electric fields are not strong enough to hurt you or your healthy cells, but they are strong enough to slow or stop cancer cells from dividing (splitting apart. When a cancer cell divides, it creates even more cancer cells
Novocure has grown from a market cap of $1.87B in 2015 to over $10B currently – a nearly 500% increase
Tuba: Please tell us about your company, its mission and how it is reimagining your industry?
William:Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy, Tumor Treating Fields, also known as TTFields.
Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, or GBM, and for the treatment of adult patients with malignant pleural mesothelioma, or MPM.
Our company is reimagining the industry by putting patients first in our goal to deliver innovative cancer therapy.
Tuba: How would you describe Novocure’s clinical pipeline and overall product portfolio?
William:We believe our mechanism of action is broadly applicable across a variety of solid tumors. Currently, we are focused on cancers of the brain, torso and abdomen.
Our Optune® device is currently approved for two indications of Glioblastoma, also called glioblastoma multiforme, which is the most aggressive type of malignant primary brain tumor. In 2019, we received our first torso indication with the approval of the Optune Lua ® device to help treat malignant pleural mesothelioma, a tumor of the tissue that lines the lungs, stomach, heart, and other organs.
With a focus on treating rare and aggressive cancers, we are also studying our Tumor Treating Fields technology in 6 additional indications, including four late-stage clinical trial programs in brain metastasis, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
We continue the effort to extend our pipeline by building pre-clinical evidence for Tumor Treating Fields in additional solid tumor cancers
Tuba: What are Tumor Treating Fields (TTFields) and how do they help fight the most deadly cancers?
William:TTFields are low-intensity, wave-like electric fields. These invisible electric fields are not strong enough to hurt you or your healthy cells, but they are strong enough to slow or stop cancer cells from dividing (splitting apart. When a cancer cell divides, it creates even more cancer cells. TTFields may destroy some cancer cells completelyTTFields but have not been shown to affect healthy cells.
Tuba: I hear you are celebrating a couple of different 5-year anniversaries for both your IPO and an FDA approval in glioblastoma. How have you seen the glioblastoma business change and grow since that approval?
A4: Shortly after our IPO, we began our commercial launch for our second Indication in GBM in the U.S. and our device is now marketed in eight active markets, the U.S., Austria, Germany, Israel, Japan, Sweden, Switzerland and most recently in China. To date, we have treated more than 17,000 patients globally with 3,361 active patients on Optune at the end of Q3 2020. Additionally, we have broadened access to Optune with more than 500 million covered lives globally.
Tuba: From a financial standpoint, how have you seen the company evolve in the past five years?
William:Novocure has grown from a market cap of $1.87 billion in 2015 to over $10 billion currently – a nearly 500% increase.
Most recently, Novocure announced that the company delivered another record quarter of financial performance, with net revenues for the quarter ending September 30, 2020, at $132.7 million, representing 44% growth compared to the third quarter of 2019. We also had a quarterly net income of $9.3M with a $0.09 in earnings per share in Q3 2020.
Our investment in R&D to support the continued advancement of Tumor Treating Fields’ science and technology has also grown. In Q3 2020, we invested $33M in R&D in comparison to $19M in Q3 2019.
Tuba: Can you tell us about some ongoing collaborations, specifically your recently announced strategic alliance with the NYU Grossman School of Medicine’s Department of Radiation Oncology?
William:Zai Lab’s early launch of Optune in China in 2020 was a success. The goal of this collaboration was to commercialize Optune in mainland China, as well as to accelerate development in other solid tumor indications. It became the first innovative medical device supported by commercial health insurance in China.
Additionally, we recently announced our alliance with the NYU Grossman School of Medicine’s Department of Radiation. The partnership establishes NYU as a center for Tumor Treating Fields’ research and development. The goal of the collaboration is to expand understanding of the interaction between Tumor Treating Fields and radiation therapy, to study Tumor Treating Fields in combination with various pharmacological agents, and to identify new indications for use. This translational research is intended to deepen the understanding of Tumor Treating Fields’ effects on cancer and to fuel the development of new treatment strategies.
Tuba: What do you like best about working at Novocure?
William:At Novocure, patients remain at the heart of the work we do every day. What I like best about working at Novocure is having the ability to help drive the company’s efforts in the development and delivery of a completely different type of cancer therapy that could lengthen the lives of patients while maintaining their quality of life.
About William F. Doyle:
William F. Doyle is an Executive Chairman at Novocure 2009 and has been a director since 2004.
The P-l trial will evaluate the safety, tolerability, and PK of ReS19-T for the treatment of AD. In preclinical studies, ReS19-T has shown to robustly restore synaptic plasticity with an acute response and improve inflammation and AD pathology over a longer treatment duration
reMYND has a broad pipeline of novel programs in development, with a diabetes program scheduled to initiate human trials in mid-2021
RES19-T is a novel approach addressing the AD at its root and restore cognition in patients by reducing the cellular damage associated with memory loss
Click here to read full press release/ article | Ref: Globe Newswire | Image: reMYND
Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety
Click here to read full press release/ article | Ref: PRNewswire | Image: GMP News
The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with active PsA who had an inadequate response to SOC &
Who were biologic-naïve only and had an inadequate response to SOC respectively
Combined results: achieved 1EPs of ACR20 @24wks.; improvements in quality of life scores; improvement in PASI 75, PASI 90, and PASI 100 rates. In DISCOVER-2 study, @24wks. less radiographic progression in both groups Tremfya is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of PsA and PsO
Click here to read full press release/ article | Ref: Janssen | Image: The Pharma Letter
The enrollment of the first P-III study is currently underway & has reached 85% of its enrollment goal. In a P-II study of 336 patients, NOV03 met its 1EP of efficacy i.e. improvement of total corneal fluorescein staining over control @8wks.
Additionally, NOV03 showed improvement of certain symptoms, such as severity & frequency of dryness & burning/stinging of the eyes, over the entire duration of the P-II study with no notable safety events
NOV03 is an investigational, water-free & preservative-free solution, based on patented EyeSol technology from Novaliq
Click here to read full press release/ article | Ref: PRNewswire | Image: SPJNews
The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients
The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 tested 2EPs
In ILLUMINATE-B, Oxlumo demonstrated a 72% mean reduction in spot urinary oxalate: creatinine ratio from baseline to 6mos., reduction of oxalate as consistent across all three body wt. categories. Additionally, therapy demonstrated positive results across 2EPs, including additional measures of oxalate
Click here to read full press release/ article | Ref: Businesswire | Image: Bloomberg
The Progeria Research Foundation and Eiger reported the US FDA’s approval of Zokinvy (lonafarnib) for the treatment of HGPS or progeria and processing-deficient progeroid laminopathies
Zokinvy reduced the incidence of mortality by 60% & increased the average survival time by 2.5 yrs. Additionally, the FDA has issued an RPD priority review voucher to Eiger
Eiger plans to sell the PRV and will share the proceeds equally with PRF, under its supply & collaboration agreement. Zokinvy is a farnesyltransferase inhibitor that has shown a survival benefit in children with Progeria
Click here to read full press release/ article | Ref: Eiger Bio | Image: PRNewswire
The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting
Results: reduction in viral load & rates of symptoms & hospitalization, frequency & types of AEs are similar
Health Canada authorized the therapy for the use of bamlanivimab (LY-CoV555) as a treatment for adults & pediatric patients aged≥12yrs. with mild to mod. COVID-19 who weigh at least 40 kg & are at high risk of progressing to severe COVID-19 illness or hospitalization
Click here to read full press release/ article | Ref: PRNewswire | Image: Microbioz India
Mesoblast to receive $25M up front and $25M as equity investment with additional payments and royalties on achievement of development, regulatory and commercial milestones
Novartis to acquire the exclusive WW rights to develop, commercialize & manufacture remestemcel-L for ARDS & access to a cell-therapy based platform with WW rights to a range of potential indications. Novartis has the option to distribute remestemcel-L for GVHD (outside Japan)
Both parties have rights to co-fund development & commercialization for other non-respiratory indications. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing P-III study while Novartis plans to initiate a P-III study in non-COVID-19-related ARDS
Click here to read full press release/ article | Ref: Novartis | Image: Market Watch
The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the treatment of symptomatic COVID-19 in the outpatient setting. The EUA is granted for bamlanivimab (LY-CoV555, 700 mg)
Patients showed reduced viral load & rates of symptoms & hospitalization. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions
The US government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication. Bamlanivimab should be administered asap after a positive COVID-19 test and within 10 days of symptom onset
Click here to read full press release/ article | Ref: Eli Lilly | Image: Business Standard
The approval is based on the RANGER II SFA pivotal study assessing the Ranger DCB vs standard PTA for the treatment in patients with PAD in the SFA & PPA
The study met its both 1EPs @12mos. i.e. MAE (94.1% vs 83.5%); lesion revascularization rate (5.5% vs 16.5%); Binary primary patency (82.9% vs 66.3%); primary patency by Kaplan-Meier estimate (89.8% vs 74.0%). The DCB has demonstrated 90% primary patency in COMPARE trial
The company expects to initiate a registry of the Ranger DCB and the Eluvia stent in the coming months to gather additional RWE and plans to launch the device in the US
Click here to read the full press release/ article | Ref: PRNewswire | Image: Forbes
The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)
Click here to read the full press release/ article | Ref: Businesswire | Image: Brand Branders
The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count
Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula reduced the risk of disease progression or death vs. pbo by 57% and the risk of disease progression or death vs. pbo by 38% in the overall population. Additionally, risk of progression in those with BRCA mutation tumours showed 60% reduction
Zejula is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. It is the first PARP inhibitor approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer
Click here to read the full press release/ article | Ref: Abbvie | Image: Spiegel
The additional insight from the P-IIb CaLIPSO study showed that SNF472 slowed the progression of CAC across key subgroups of patients on hemodialysis participating in the study. The presentation highlights the PK/PD and exposure-response analyses
Sanifit also presents the design of its ongoing P-III CALCIPHYX study evaluating the efficacy and safety of SNF472 for the treatment of patients with calciphylaxis (calcific uremic arteriolopathy, or CUA). Additional data demonstrated that SNF472 strongly inhibits valvular calcification in an in vitro model of porcine aortic valve
SNF472 is an inhibitor of vascular calcification currently in P-III study, acts by targeting the deposition of solid calcium (hydroxyapatite, HAP) in the CV system. The company is showcasing new data on SNF472 in four presentations including one oral session and three ePoster sessions at virtual ASN Kidney Week 2020
Click here to read full press release/ article | Ref: Sanifit | Image: European Biotechnology
AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent
The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or until disease recurrence in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21
Click here to read full press release/ article | Ref: AstraZeneca | Image: The Print
The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials
P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi Aerosphere over 52wks. In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators
Trixeo Aerosphere is a single-inhaler, fixed-dose triple combination of formoterol fumarate, glycopyrronium bromide with budesonide, delivered in a pressurized metered-dose inhaler, and is approved under the brand name Breztri Aerosphere in Japan, China & the US for COPD
Click here to read full press release/ article | Ref: AstraZeneca | Image: TeleTrader.com
The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA.
Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein
Click here to read the full press release/ article | Ref: PR Newswire | Image: Stat
The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status
The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to 1L Pt.-based CT
Zejula (PO, qc) is a poly (ADP-ribose) polymerase (PARP) inhibitor and has received approval in 2019, in Canada for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Click here to read full press release/ article | Ref: GSK | Image: Pharmafile
The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies
Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease worsening or death (PFS); @primary analysis, median survival follow up time (8.6mos.); 7.6mos. delay in median time to deterioration of patient-reported QoL
The approval is part of Project Orbis, an initiative of the FDA’s OCE which provides a framework for simultaneous submission and review of oncology products among international partners
Click here to read full press release/ article | Ref: Roche | Image: SOM
The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline
The expected PDUFA date for the therapy as Feb 11, 2021. The US FDA has granted BT designation to the therapy for the treatment of hypercholesterolemia in patients with HoFH in 2017
Evinacumab is an investigational mAb that binds to and blocks the function of ANGPTL3 and is currently being studied in patients with HoFH (ongoing P-III extension trial), refractory hypercholesterolemia (P-II) and severe hypertriglyceridemia (P-II)
Click here to read full press release/ article | Ref: Regeneron | Image: CNN
Cadila has launched NuPTH an osteoporosis biosimilar of Forteo in India. The NuPTH is used for the treatment of osteoporosis and in patients with increased risk of fracture. The biosimilar NuPTH aims to be cost-effective for patients and will be available as easy to use, pre-filled disposable pen
NuPTH is the third biosimilar launched by the company following the launch of Rituximab and Bevacizumab biosimilars, recommended in multiple indications under the brand names Ritucad and Bevaro respectively
The launch strengthens the company’s ortho care portfolio and helps in increasing choice and access for osteoporosis care to patients in the Indian Market
Click here to read full press release/ article | Ref: Cadila Pharma | Image: Cadila Pharma
The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients
The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile compared with Darzalex IV in patients with RRMS, 2/3rd reduction in systemic ARRs (13% vs 34%)
In P-II PLEIADES study evaluates Darzalex SC + D-VMP in newly diagnosed transplant-ineligible patients & Darzalex SC + (D-Rd) in R/R patients prior treated with 1L therapy. In general, Darzalex SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions
Click here to read full press release/ article | Ref: PRNewswire | Image: Explore
The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
Equidacent will be available as 25 mg/ml as the solution for infusion targeting VEGF and act by inhibiting the binding of VEGF to its receptors on endothelial cell
The company anticipates EC’s decision in ~60days. The clinical data demonstrated that Equidacent has comparable quality, safety, and efficacy to Avastin
Click here to read full press release/ article | Ref: PRNewswire | Image: PharmaShots
This analysis and series of state fact sheets examine mental health and substance use disorder needs in the states and capacity to meet residents’ needs prior to the COVID-19 pandemic, which is expected to place additional strains on the system.
The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months
The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to be approved in China and the candidate’s NDA has also received NMPA’s Priority Review while BeiGene is currently working with BI for its commercial supply to launch in China
Tislelizumab (BGB-A317, 200mg, IV) is a humanized IgG4 anti–PD-1 mAb targeted to minimize binding to FcγR on macrophages and is been evaluated as a monothx and in combination to treat multiple solid tumor and hematologic cancers with 15 registration-enabling trials conducted in China and globally, including 11 P-III trials and 4 pivotal P-II trials
Click here to read full press release/ article | Ref: BeiGene | Image: Twitter
The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks on 1L Pt-based chemotherapy
The study resulted in improvement in median progression-free survival (7.4 mos. vs 3.8 mos.), 47% reduced risk of disease progression or death, respond ratio (23% vs 12%), median duration of treatment in excess of 2 yrs. (24.9 mos. vs 3.7 mos.), OS (18.9 mos. vs 18.1 mos.), safe and tolerable
AstraZeneca and Merck & Co’s (MSD outside the United States and Canada) Lynparza (olaparib) is a first-in-class PARP inhibitor targeted to block DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination repair (HRR) and is approved in 65 countries
Click here to read full press release/ article | Ref: AstraZeneca | Image: Signbox